Medical device makers in the United States: 8,820 FDA-registered establishments

Name: FDA-registered medical device makers in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

8,820 establishments in the United States are registered with the FDA to make medical devices for the US market, listing 4,935 device types. 4,496 have a 510(k) clearance or PMA approval on file and 1,403 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Orthopedic Manual Surgical Instrument	LXH	490
Screw, Fixation, Bone	HWC	301
Tray, Surgical, Instrument	FSM	289
Electrosurgical, Cutting & Coagulation & Accessories	GEI	272
Instrument, Manual, Surgical, General Use	MDM	243
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	241
Bit, Drill	HTW	239
Plate, Fixation, Bone	HRS	238
Guide, Surgical, Instrument	FZX	236
System, Image Processing, Radiological	LLZ	235
Retractor	GAD	230
Thoracolumbosacral Pedicle Screw System	NKB	224
Orthopedic Stereotaxic Instrument	OLO	222
Template	HWT	222
Appliance, Fixation, Spinal Intervertebral Body	KWQ	218
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	217
Screwdriver	HXX	213
Tape And Bandage, Adhesive	KGX	198
Appliance, Fixation, Spinal Interlaminal	KWP	195
Orthosis, Spinal Pedicle Fixation	MNI	194
Orthosis, Spondylolisthesis Spinal Fixation	MNH	189
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	172
Gauge, Depth	HTJ	170
Reamer	HTO	156
Sunglasses (Non-Prescription Including Photosensitive)	HQY	154
Tap, Bone	HWX	152
Impactor	HWA	151
Awl	HWJ	148
Orthosis, Limb Brace	IQI	147
Laparoscope, General & Plastic Surgery	GCJ	146
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	146
Syringe, Piston	FMF	145
Medical Device Data System	OUG	145
Spinal Vertebral Body Replacement Device	MQP	144
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	143
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	137
Forceps	HTD	136
Wrench	HXC	136
Support, Patient Position	CCX	130
Extractor	HWB	130
Rod, Fixation, Intramedullary And Accessories	HSB	129
Powered Laser Surgical Instrument	GEX	129
Catheter, Percutaneous	DQY	127
Probe	HXB	127
Arthroscope	HRX	126
Tamp	HXG	124
Washer, Bolt Nut	HTN	123
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	122
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	122
General Purpose Reagent	PPM	119
Accessories, Arthroscopic	NBH	118
Rasp	HTR	118
Sacroiliac Joint Fixation	OUR	118
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	117
Set, Administration, Intravascular	FPA	117
Tape, Measuring, Rulers And Calipers	FTY	117
Dressing, Wound, Drug	FRO	116
Pin, Fixation, Smooth	HTY	114
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	114
Cannula, Surgical, General & Plastic Surgery	GEA	114
Introducer, Catheter	DYB	113
Protector, Skin Pressure	FMP	113
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	112
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	110
Neurological Stereotaxic Instrument	HAW	110
Staple, Fixation, Bone	JDR	108
Bandage, Elastic	FQM	108
Accessories, Implant, Dental, Endosseous	NDP	107
Pack, Hot Or Cold, Reusable	IME	107
System, Imaging, Pulsed Echo, Ultrasonic	IYO	106
Abutment, Implant, Dental, Endosseous	NHA	105
Transducer, Ultrasonic, Diagnostic	ITX	105
Bender	HXW	105
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	103
Posterior Cervical Screw System	NKG	101
Clamp	HXD	101
Driver, Prosthesis	HWR	101
Continuous Measurement Thermometer	FLL	101
Massager, Therapeutic, Electric	ISA	100
Needle, Hypodermic, Single Lumen	FMI	99
Lamp, Infrared, Therapeutic Heating	ILY	99
Joint, Ankle, External Brace	ITW	98
Splint, Hand, And Components	ILH	97
Tray, Surgical	LRP	96
Joint, Knee, External Brace	ITQ	95
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	94
Filler, Bone Void, Calcium Compound	MQV	94
Accessory, Surgical Apparel	LYU	94
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	94
Curette	HTF	93
Blade, Saw, General & Plastic Surgery, Surgical	GFA	92
Frame, Spectacle	HQZ	91
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	90
Bedding, Disposable, Medical	KME	90
Osteotome	HWM	90
Oximeter	DQA	90
Mallet	HXL	89
Needle, Aspiration And Injection, Disposable	GAA	88
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	87
Pin, Fixation, Threaded	JDW	87

Makers in the United States

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Biomet, Inc.	Warsaw, IN, United States	204	613	1	254	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	173	597	2	74	api.fda.gov
Karl Storz Endoscopy-America, Inc.	El Segundo, CA, United States	220	464	1	27	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	118	455	9	43	api.fda.gov
Karl Storz Endoscopy-America, Inc.	Auburn, MA, United States	207	436	1	7	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	547	421	5	135	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	121	378	0	18	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	247	354	17	129	api.fda.gov
Boston Scientific Corporation	Saint Paul, MN, United States	167	318	47	86	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	138	362	1	105	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	618	357	0	249	api.fda.gov
Deroyal Industries, Inc.	Powell, TN, United States	357	351	0	51	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	202	334	4	95	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	141	330	1	267	api.fda.gov
Integra LifeSciences Corporation	Princeton, NJ, United States	429	317	5	124	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	85	313	6	6	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Newark, DE, United States	160	303	3	180	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	113	302	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	132	294	5	86	api.fda.gov
Boston Scientific Corporation	Coventry, RI, United States	127	270	21	0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	112	260	10	18	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	77	262	3	0	api.fda.gov
Conmed Corporation	Utica, NY, United States	113	258	1	37	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	108	258	1	15	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	463	253	0	0	api.fda.gov
Covidien	North Haven, CT, United States	74	251	1	74	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	63	240	2	226	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	101	237	3	117	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	122	219	21	3	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	45	224	2	0	api.fda.gov
Gyrus ACMI, Inc.	Brooklyn Park, MN, United States	151	221	1	6	api.fda.gov
Zapalign LLC	Fort Lauderdale, FL, United States	174	213	0	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	82	212	0	26	api.fda.gov
Coopersurgical, Inc.	Trumbull, CT, United States	98	211	0	71	api.fda.gov
Icu Medical, Inc.	San Clemente, CA, United States	92	211	0	45	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	92	209	1	20	api.fda.gov
Cardinal Health	Hazelwood, MO, United States	164	207	1	0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	60	205	2	6	api.fda.gov
O&M Halyard, Inc.	Alpharetta, GA, United States	127	207	0	3	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	102	205	0	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	86	201	1	15	api.fda.gov
Medtronic Distribution Center	Memphis, TN, United States	110	164	33	0	api.fda.gov
Jersey Dental Supplies	Lakewood, NJ, United States	52	195	1	0	api.fda.gov
Depuy Orthopaedics	Bridgewater, MA, United States	154	194	1	0	api.fda.gov
Intuitive Surgical, Inc.	Santa Clara, CA, United States	29	190	0	0	api.fda.gov
Merit Medical Systems, Inc.	South Jordan, UT, United States	122	188	1	89	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	94	187	0	29	api.fda.gov
Intuitive Surgical, Inc.	Sunnyvale, CA, United States	26	182	0	122	api.fda.gov
Medtronic Perfusion Systems	Minneapolis, MN, United States	46	181	0	55	api.fda.gov
Bausch & Lomb Incorporated	Rochester, NY, United States	205	144	29	25	api.fda.gov
Bard Access Systems, Inc.	Salt Lake City, UT, United States	50	172	0	40	api.fda.gov
Linvatec Corporation	Largo, FL, United States	89	172	0	35	api.fda.gov
SunMed Group Holdings, LLC	Grand Rapids, MI, United States	132	171	1	26	api.fda.gov
Boston Scientific Corporation	Marlborough, MA, United States	114	167	4	82	api.fda.gov
Stryker Endoscopy	San Jose, CA, United States	110	170	0	64	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	109	161	0	4	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	95	155	4	24	api.fda.gov
Carefusion 2200, Inc.	Vernon Hills, IL, United States	64	157	0	18	api.fda.gov
Teco Diagnostics	Anaheim, CA, United States	122	157	0	3	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	66	154	0	36	api.fda.gov
Aesculap, Inc.	Center Valley, PA, United States	318	144	0	66	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	655	143	0	8	api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, United States	193	143	0	0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	102	140	3	15	api.fda.gov
Remel, Inc.	Lenexa, KS, United States	73	143	0	74	api.fda.gov
Stryker Instruments	Portage, MI, United States	101	142	0	18	api.fda.gov
Deroyal Industries, Inc.	New Tazewell, TN, United States	203	141	0	3	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	69	139	2	96	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	51	139	0	14	api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, United States	49	138	0	116	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	63	137	0	71	api.fda.gov
St. Jude Medical, Cardiology Division, Inc.	Plymouth, MN, United States	43	126	11	25	api.fda.gov
Ansell Healthcare Products LLC	Reno, NV, United States	16	131	0	3	api.fda.gov
Biomerieux, Inc.	Hazelwood, MO, United States	19	129	1	41	api.fda.gov
Cook Incorporated	Spencer, IN, United States	100	129	1	9	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	46	129	0	12	api.fda.gov
Horiba Instruments Incorporated	Canton, MI, United States	98	128	0	32	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	137	120	7	135	api.fda.gov
Medtronic, Inc.	Mounds View, MN, United States	46	99	27	95	api.fda.gov
Respironics Inc.	Murrysville, PA, United States	43	122	0	65	api.fda.gov
Bard Peripheral Vascular, Inc.	Tempe, AZ, United States	48	114	7	68	api.fda.gov
Beckman Coulter, Inc.	Brea, CA, United States	128	118	0	356	api.fda.gov
Boston Scientific Corporation	Maple Grove, MN, United States	46	106	12	99	api.fda.gov
Medtronic Xomed, Inc.	Jacksonville, FL, United States	82	116	0	25	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	51	115	0	9	api.fda.gov
Icu Medical, Inc.	Lake Forest, IL, United States	32	114	0	88	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Raritan, NJ, United States	124	107	7	16	api.fda.gov
Zeus Scientific LLC	Branchburg, NJ, United States	61	112	2	11	api.fda.gov
ConMed Corporation	Greenwood Village, CO, United States	33	113	0	9	api.fda.gov
Medical Components Inc	Harleysville, PA, United States	34	113	0	23	api.fda.gov
Baxter Healthcare Corporation	Round Lake, IL, United States	58	106	6	106	api.fda.gov
Inova Diagnostics, Inc.	San Diego, CA, United States	46	112	0	3	api.fda.gov
Stryker Spine	Allendale, NJ, United States	36	112	0	49	api.fda.gov
Argon Medical Devices Inc.	Athens, TX, United States	76	108	0	30	api.fda.gov
Avanos Medical, Inc.	Alpharetta, GA, United States	61	107	1	48	api.fda.gov
Bio-Rad Laboratories Inc.	Irvine, CA, United States	19	108	0	0	api.fda.gov
Bio-Rad Laboratories Inc.	Irvine, CA, United States	18	107	0	1	api.fda.gov
Beckman Coulter, Inc.	West Sacramento, CA, United States	17	106	0	16	api.fda.gov
Djo, LLC	Carlsbad, CA, United States	106	103	2	4	api.fda.gov
GC America Inc.	Alsip, IL, United States	38	105	0	0	api.fda.gov
Ge Parallel Design, Inc.	Phoenix, AZ, United States	8	104	1	0	api.fda.gov
Abbott Vascular	Temecula, CA, United States	32	91	13	31	api.fda.gov
Life Spine	Huntley, IL, United States	22	104	0	0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	E Walpole, MA, United States	96	89	15	74	api.fda.gov
Diagnostica Stago, Inc.	Parsippany, NJ, United States	33	103	0	30	api.fda.gov
Medtronic Navigation, Inc.	Lafayette, CO, United States	25	103	0	58	api.fda.gov
Microgenics Corporation	Fremont, CA, United States	67	103	0	14	api.fda.gov
Becton Dickinson	Franklin Lakes, NJ, United States	52	102	0	129	api.fda.gov
Becton, Dickinson And Company	Irvine, CA, United States	36	101	0	2	api.fda.gov
Customed, Inc.	Fajardo, PR, United States	111	101	0	5	api.fda.gov
ZimVie US Corp LLC	Palm Beach Gardens, FL, United States	9	101	0	60	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	75	100	0	27	api.fda.gov
Spinal Elements, Inc.	Carlsbad, CA, United States	29	99	0	3	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	75	98	0	0	api.fda.gov
Cook Medical LLC	Bloomington, IN, United States	67	90	8	8	api.fda.gov
Compass Health Brands (corporate Office)	Middleburg Heights, OH, United States	119	97	0	4	api.fda.gov
Philips North America LLC	Cambridge, MA, United States	60	97	0	77	api.fda.gov
Solventum Us LLC	Eagan, MN, United States	75	97	0	0	api.fda.gov
Solventum US LLC	San Antonio, TX, United States	78	97	0	0	api.fda.gov
Covidien	Lafayette, CO, United States	45	96	0	41	api.fda.gov
Nuvasive, Inc.	Guaynabo, PR, United States	42	94	1	0	api.fda.gov
Cynosure, LLC	Westford, MA, United States	23	94	0	1	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	273	94	0	0	api.fda.gov
St. Jude Medical	Roseville, MN, United States	32	76	17	0	api.fda.gov
Covidien	Lafayette, CO, United States	11	91	0	2	api.fda.gov
INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, United States	53	91	0	0	api.fda.gov
Cliniqa Corporation	San Marcos, CA, United States	54	90	0	0	api.fda.gov
Philips Ultrasound LLC	Bothell, WA, United States	9	90	0	29	api.fda.gov
Covidien	Boulder, CO, United States	11	88	0	7	api.fda.gov
Cordis US Corp.	Miami Lakes, FL, United States	22	79	7	52	api.fda.gov
Kerr Corporation	Orange, CA, United States	45	86	0	29	api.fda.gov
Penumbra Inc.	Roseville, CA, United States	12	86	0	0	api.fda.gov
Covidien	Ponce, PR, United States	27	85	0	1	api.fda.gov
Ethicon Endo-Surgery, LLC	Guaynabo, PR, United States	18	85	0	1	api.fda.gov
Hardy Diagnostics	Orcutt, CA, United States	32	85	0	18	api.fda.gov
B. Braun Medical Inc.	Bethlehem, PA, United States	43	84	0	11	api.fda.gov
Penumbra, Inc.	Alameda, CA, United States	11	84	0	8	api.fda.gov
Penumbra Inc.	Livermore, CA, United States	11	84	0	1	api.fda.gov
Penumbra Inc.	Salt Lake City, UT, United States	11	84	0	0	api.fda.gov
Zavation	Flowood, MS, United States	47	84	0	1	api.fda.gov
Beckman Coulter, Inc.	Chaska, MN, United States	69	78	4	43	api.fda.gov
Bio-Rad Laboratories, Inc.	Hercules, CA, United States	73	82	0	40	api.fda.gov
Fisher Diagnostics	Middletown, VA, United States	118	81	0	5	api.fda.gov
Helena Laboratories, Corp.	Beaumont, TX, United States	47	79	0	14	api.fda.gov
VIVE Health LLC	Naples, FL, United States	116	79	0	0	api.fda.gov
Instrumentation Laboratory Co.	Bedford, MA, United States	45	78	0	39	api.fda.gov
Ultradent Products Inc.	South Jordan, UT, United States	48	78	0	13	api.fda.gov
Ethicon Endo-Surgery, Inc.	Cincinnati, OH, United States	20	77	0	47	api.fda.gov
Medtronic Neurosurgery	Fort Worth, TX, United States	21	77	0	20	api.fda.gov
Acumed LLC	Hillsboro, OR, United States	31	76	0	22	api.fda.gov
Applied Medical Resources Corp.	Rsm, CA, United States	30	76	0	24	api.fda.gov
Biomet Microfixation	Jacksonville, FL, United States	150	75	1	36	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	76	75	1	1	api.fda.gov
MicroVention, Inc.	Aliso Viejo, CA, United States	24	72	4	17	api.fda.gov
Resmed Corp	San Diego, CA, United States	21	76	0	3	api.fda.gov
Signa Medical, Inc.	Long Beach, NY, United States	72	76	0	0	api.fda.gov
ev3, Inc.	Plymouth, MN, United States	21	71	5	40	api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 Neurovascular	Irvine, CA, United States	19	73	2	4	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	56	75	0	22	api.fda.gov
Applied Medical Distribution Center	Irvine, CA, United States	30	73	0	0	api.fda.gov
Biosense Webster, Inc.	Irvine, CA, United States	11	65	8	4	api.fda.gov
C.R. Bard, Inc.	Covington, GA, United States	162	73	0	66	api.fda.gov
Ge Medical Systems, LLC	Waukesha, WI, United States	9	73	0	12	api.fda.gov
United States Endoscopy Group, Inc.	Mentor, OH, United States	51	73	0	10	api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center	Quincy, MA, United States	52	61	11	39	api.fda.gov
Choice Spine LLC	Knoxville, TN, United States	20	72	0	0	api.fda.gov
Abbott Vascular	Santa Clara, CA, United States	24	59	11	1	api.fda.gov
Beckman Coulter, Inc.	Miami, FL, United States	47	69	0	13	api.fda.gov
Carolina Liquid Chemistries	Brea, CA, United States	57	69	0	2	api.fda.gov
DeRoyal Industries, Inc.	New Tazewell, TN, United States	134	69	0	2	api.fda.gov
Steris Corporation	Mentor, OH, United States	12	69	0	0	api.fda.gov
Stryker Neurovascular	Fremont, CA, United States	17	67	2	23	api.fda.gov
AngioDynamics, Inc.	Marlborough, MA, United States	26	68	0	4	api.fda.gov
Nova Biomedical Corporation	Waltham, MA, United States	57	68	0	15	api.fda.gov
Prismatik Dentalcraft, Inc.	Irvine, CA, United States	33	68	0	4	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	32	68	0	1	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	60	67	0	0	api.fda.gov
Edwards Lifesciences Technology Sarl	Anasco, PR, United States	32	66	0	3	api.fda.gov
Stryker Sustainability Solutions	Tempe, AZ, United States	25	66	0	35	api.fda.gov
Ge Medical Systems, LLC	Waukesha, WI, United States	17	65	0	426	api.fda.gov
Instrumentation Laboratory Co.	Orangeburg, NY, United States	44	65	0	0	api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 Neurovascular	Irvine, CA, United States	17	63	2	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	63	65	0	32	api.fda.gov
Canon Medical Informatics, Inc.	Minnetonka, MN, United States	10	64	0	10	api.fda.gov
Conmed Corporation	Westborough, MA, United States	42	63	1	1	api.fda.gov
GE Healthcare Coils	Aurora, OH, United States	6	64	0	4	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	157	64	0	0	api.fda.gov
Angiodynamics, Inc.	Queensbury, NY, United States	25	63	0	28	api.fda.gov
Millennium Surgical Corp	Schaumburg, IL, United States	247	63	0	0	api.fda.gov
Siemens Healthcare Diagnostics Inc	East Walpole, MA, United States	59	63	0	35	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	84	62	0	0	api.fda.gov
Euroimmun Us Inc.	Mountain Lakes, NJ, United States	78	62	0	0	api.fda.gov
Implantech Associates, Inc.	Ventura, CA, United States	18	62	0	2	api.fda.gov
Princeton Biomeditech Corp.	Monmouth Jct, NJ, United States	43	62	0	2	api.fda.gov
Princeton BioMeditech Corp.	Plainsboro, NJ, United States	40	62	0	0	api.fda.gov
Princeton BioMeditech Corp.	Skillman, NJ, United States	40	62	0	0	api.fda.gov
Allied Medical LLC	Earth City, MO, United States	61	61	0	2	api.fda.gov
Dentsply LLC	Milford, DE, United States	36	61	0	0	api.fda.gov
Hemagen Diagnostics, Inc.	Baltimore, MD, United States	43	61	0	0	api.fda.gov
Osteomed	Addison, TX, United States	59	61	0	4	api.fda.gov
Philips Ultrasound LLC	Cambridge, MA, United States	8	61	0	0	api.fda.gov
STERIS Corporation	Mentor, OH, United States	9	61	0	4	api.fda.gov
Straumann Manufacturing, Inc.	Andover, MA, United States	4	61	0	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	54	60	0	0	api.fda.gov
Paragon 28	Englewood, CO, United States	51	60	0	10	api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)	Morrisville, NC, United States	27	59	0	13	api.fda.gov
ArthroCare Corporation	Austin, TX, United States	21	59	0	17	api.fda.gov
Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, United States	13	59	0	95	api.fda.gov
Meridian Bioscience, Inc.	Cincinnati, OH, United States	51	59	0	16	api.fda.gov
Boston Scientific Corporation	Spencer, IN, United States	50	57	1	25	api.fda.gov
Ethicon, Inc.	Raritan, NJ, United States	32	54	4	4	api.fda.gov
Integra Lifesciences Corporation	Cincinnati, OH, United States	184	58	0	6	api.fda.gov
Katmai Health Services LLC	Brilliant, OH, United States	61	58	0	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	45	58	0	0	api.fda.gov
Trinity Biotech USA	Jamestown, NY, United States	41	58	0	9	api.fda.gov
Medtronic Grand Rapids	Grand Rapids, MI, United States	20	57	0	0	api.fda.gov
Hologic, Inc.	Marlborough, MA, United States	39	53	3	16	api.fda.gov
Pulpdent Corporation	Watertown, MA, United States	37	56	0	0	api.fda.gov
Vascular Solutions LLC	Maple Grove, MN, United States	28	54	2	22	api.fda.gov
Abbott Medical	Sylmar, CA, United States	33	44	11	38	api.fda.gov
Abbott Laboratories	Irving, TX, United States	71	54	0	10	api.fda.gov
Becton Dickinson Caribe Ltd.	Cayey, PR, United States	10	54	0	0	api.fda.gov
ConvaTec, Inc.	Greensboro, NC, United States	70	54	0	37	api.fda.gov
Enablecv, LLC	Midvale, UT, United States	11	54	0	0	api.fda.gov
Sterngold Dental LLC	Attleboro, MA, United States	15	54	0	0	api.fda.gov
Tosoh Bioscience, Inc.	Grove City, OH, United States	57	53	1	30	api.fda.gov
Atricure, Inc.	Mason, OH, United States	19	51	2	9	api.fda.gov
Den-Mat Holdings, LLC	Lompoc, CA, United States	42	53	0	1	api.fda.gov
MINDRAY DS USA, Inc.	Mahwah, NJ, United States	60	53	0	55	api.fda.gov
Philips Ultrasound LLC	Reedsville, PA, United States	7	53	0	3	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	35	53	0	3	api.fda.gov
STERIS Corporation	Saint Louis, MO, United States	212	53	0	0	api.fda.gov
Young Innovations Inc.	Algonquin, IL, United States	88	53	0	0	api.fda.gov
Cepheid	Sunnyvale, CA, United States	38	52	0	15	api.fda.gov
Ethicon, Inc.	Somerville, NJ, United States	30	49	3	47	api.fda.gov
Intuitive Surgical, Inc.	Peachtree Corners, GA, United States	12	52	0	0	api.fda.gov
Nihon Kohden America, Inc.	Irvine, CA, United States	49	52	0	12	api.fda.gov
Masimo Corporation	Irvine, CA, United States	42	51	0	3	api.fda.gov
Zest Anchors, LLC	Carlsbad, CA, United States	29	51	0	3	api.fda.gov
American Diagnostic Corp.	Hauppauge, NY, United States	31	50	0	0	api.fda.gov
Cerenovus, Inc.	Miami, FL, United States	13	49	1	1	api.fda.gov
Collagen Matrix, Inc.	Mahwah, NJ, United States	14	50	0	0	api.fda.gov
Kerr Corporation	Pomona, CA, United States	65	50	0	0	api.fda.gov
Sanzay Corporation -	Miami Gardens, FL, United States	66	50	0	0	api.fda.gov
Siemens Medical Solutions Usa, Inc.	Issaquah, WA, United States	9	50	0	10	api.fda.gov
STERIS Corporation	Mentor, OH, United States	8	50	0	0	api.fda.gov
Welch Allyn, Inc.	Skaneateles Falls, NY, United States	53	50	0	6	api.fda.gov
Cepheid	Lodi, CA, United States	36	49	0	0	api.fda.gov
Eagle Medical Packaging Sterilization, Inc.	Paso Robles, CA, United States	39	49	0	0	api.fda.gov
Germaine Laboratories, Inc.	San Antonio, TX, United States	79	49	0	0	api.fda.gov
Precision Spine, Inc.	Pearl, MS, United States	48	49	0	0	api.fda.gov
Dentsply LLC	York, PA, United States	41	48	0	0	api.fda.gov
Icu Medical, Inc	Salt Lake City, UT, United States	28	48	0	0	api.fda.gov
Metropolis International, LLC	Long Island City, NY, United States	52	46	2	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	64	48	0	22	api.fda.gov
Stanbio Laboratory	Boerne, TX, United States	83	48	0	6	api.fda.gov
Roche Molecular Systems, Inc.	Pleasanton, CA, United States	36	34	13	0	api.fda.gov
Davol Inc., Sub. C.R. Bard, Inc.	Warwick, RI, United States	20	41	5	21	api.fda.gov
Johnson & Johnson Surgical Vision, Inc.	Irvine, CA, United States	20	35	11	8	api.fda.gov
Keystone Dental Inc.	Irvine, CA, United States	12	46	0	0	api.fda.gov
Medtronic Minimed	Northridge, CA, United States	24	38	8	62	api.fda.gov
Mozarc Medical Us LLC	Mansfield, MA, United States	18	46	0	3	api.fda.gov
Alfa Scientific Designs, Inc.	Poway, CA, United States	39	45	0	0	api.fda.gov
Abbott Medical	Plymouth, MN, United States	22	32	13	0	api.fda.gov
Bayer Medical Care Inc.	Indianola, PA, United States	15	45	0	29	api.fda.gov
Collagen Matrix, Inc.	Oakland, NJ, United States	13	45	0	3	api.fda.gov
Covidien LLC	Mansfield, MA, United States	19	45	0	54	api.fda.gov
Instrumed International Inc dba Avalign German Specialty Instruments	Schaumburg, IL, United States	241	45	0	2	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	27	45	0	6	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Athens, OH, United States	47	45	0	10	api.fda.gov
Riverpoint Medical LLC	Portland, OR, United States	29	45	0	7	api.fda.gov
Roche Molecular Systems, Inc.	Branchburg, NJ, United States	49	32	13	38	api.fda.gov
Salter Labs	El Paso, TX, United States	34	45	0	0	api.fda.gov
Stryker Sustainability Solutions Lakeland	Lakeland, FL, United States	9	45	0	5	api.fda.gov
Abbott Medical	Saint Paul, MN, United States	21	32	12	1	api.fda.gov
Alcon Research, LLC	Fort Worth, TX, United States	27	35	9	46	api.fda.gov
Medgyn Products, Inc.	Westmont, IL, United States	40	44	0	0	api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.	Saint Paul, MN, United States	17	36	8	4	api.fda.gov
Inter-Med, Inc.	Racine, WI, United States	47	43	0	2	api.fda.gov
Utah Medical Products, Inc.	Midvale, UT, United States	37	43	0	3	api.fda.gov
Biohorizons Implant Systems Inc.	Birmingham, AL, United States	8	42	0	9	api.fda.gov
Church & Dwight Co., Inc.	Princeton, NJ, United States	15	42	0	3	api.fda.gov
Datex-Ohmeda, Inc.	Madison, WI, United States	8	41	1	3	api.fda.gov
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC	Noblesville, IN, United States	4	42	0	0	api.fda.gov
Integra Neurosciences	Anasco, PR, United States	13	40	2	1	api.fda.gov
Medtronic Puerto Rico Operations Co., Villalba	Villalba, PR, United States	36	20	22	0	api.fda.gov
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	23	42	0	7	api.fda.gov
Siemens Medical Solutions Usa, Inc.	Hoffman Estates, IL, United States	6	42	0	42	api.fda.gov
Volcano Corporation	San Diego, CA, United States	20	42	0	7	api.fda.gov
Agilent Technologies Inc.	Cedar Creek, TX, United States	70	34	7	0	api.fda.gov
GE Healthcare Manufacturing LLC	Florence, SC, United States	4	41	0	1	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	53	41	0	13	api.fda.gov
Reliance Orthodontic Products, Inc.	Itasca, IL, United States	26	41	0	0	api.fda.gov
Steris Corporation	Mentor, OH, United States	4	41	0	84	api.fda.gov
Advanced Sterilization Products	Irvine, CA, United States	15	40	0	47	api.fda.gov
Medartis Inc.	Warsaw, IN, United States	45	39	1	8	api.fda.gov
Stryker Puerto Rico, LLC.	Arroyo, PR, United States	46	40	0	0	api.fda.gov
Sol-Millennium Medical, Inc.	Chicago, IL, United States	34	40	0	1	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	28	40	0	11	api.fda.gov
3D Dental Desings And Development	Shaker Heights, OH, United States	92	39	0	0	api.fda.gov
A-dec, Inc.	Newberg, OR, United States	24	39	0	1	api.fda.gov
Abyrx, Inc.	Stamford, CT, United States	5	39	0	0	api.fda.gov
Bausch & Lomb Incorporated	Saint Louis, MO, United States	27	38	1	2	api.fda.gov
Five Star Orthodontic Laboratory & Supply, Inc.	Denton, TX, United States	24	39	0	0	api.fda.gov
Solventum US LLC	Irvine, CA, United States	25	39	0	0	api.fda.gov
Vantive US Healthcare LLC	Deerfield, IL, United States	15	38	1	2	api.fda.gov
Bosma Industries For The Blind, Inc.	Indianapolis, IN, United States	11	38	0	0	api.fda.gov
Hologic, Inc.	Newark, DE, United States	15	35	3	2	api.fda.gov
Hologic, Inc.	San Diego, CA, United States	36	32	6	21	api.fda.gov
Philips North America LLC	Andover, MA, United States	39	38	0	267	api.fda.gov
Scientific Pharmaceuticals, Inc.	Pomona, CA, United States	14	38	0	0	api.fda.gov
Vygon Usa	Lansdale, PA, United States	28	38	0	10	api.fda.gov
Accutome, Inc.	Malvern, PA, United States	48	37	0	0	api.fda.gov
Bisco, Inc.	Schaumburg, IL, United States	15	37	0	1	api.fda.gov
ConforMIS, Inc.	Wilmington, MA, United States	12	37	0	3	api.fda.gov
Crosstex International	Rush, NY, United States	33	37	0	0	api.fda.gov
Gold Standard Diagnostics, LLC	Davis, CA, United States	26	37	0	0	api.fda.gov
Kyocera Medical Technologies, Inc.	Redlands, CA, United States	21	37	0	0	api.fda.gov
Lin-Zhi International, Inc.	Santa Clara, CA, United States	19	37	0	8	api.fda.gov
Medica Corp.	Bedford, MA, United States	56	37	0	5	api.fda.gov
Ocular Instruments, Inc.	Bellevue, WA, United States	9	37	0	0	api.fda.gov
Parkell, Inc.	Edgewood, NY, United States	30	37	0	0	api.fda.gov
Quality Electrodynamics	Mayfield Village, OH, United States	5	37	0	3	api.fda.gov
Varian Medical Systems, Inc	Palo Alto, CA, United States	5	37	0	123	api.fda.gov
Vygon MFG	Dover, NH, United States	35	37	0	14	api.fda.gov
Anholt Technologies Inc.	Avondale, PA, United States	19	36	0	1	api.fda.gov
Brasseler U.S.A. Dental, LLC	Savannah, GA, United States	78	36	0	1	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	42	36	0	2	api.fda.gov
Fujifilm Sonosite,inc.	Bothell, WA, United States	8	36	0	9	api.fda.gov
Innovative Health, LLC.	Scottsdale, AZ, United States	11	36	0	0	api.fda.gov
Infrared Laboratory Systems dba SYNERMED	Westfield, IN, United States	41	36	0	0	api.fda.gov
Iridex Corporation	San Jose, CA, United States	10	36	0	0	api.fda.gov
Iridex Corporation	Mountain View, CA, United States	10	36	0	3	api.fda.gov
Respironics, Inc.	Mount Pleasant, PA, United States	15	36	0	0	api.fda.gov
Skeletal Dynamics, Inc	Miami, FL, United States	17	36	0	1	api.fda.gov
Surgentec LLC	Boca Raton, FL, United States	17	36	0	0	api.fda.gov
Stryker Sustainability Solutions Phoenix	Phoenix, AZ, United States	22	36	0	3	api.fda.gov
Becton, Dickinson and Company, BD Biosciences	Milpitas, CA, United States	15	35	0	4	api.fda.gov
Electro Medical Systems, L.L.C.	Southlake, TX, United States	10	34	1	0	api.fda.gov
IMMUNO CONCEPTS, NA, Ltd.	Sacramento, CA, United States	13	35	0	2	api.fda.gov
INNO Holdings Inc.	Millcreek, UT, United States	20	35	0	7	api.fda.gov
Mako Surgical Corp.	Weston, FL, United States	21	35	0	26	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	50	35	0	19	api.fda.gov
R & D Systems, Inc.	Minneapolis, MN, United States	10	35	0	7	api.fda.gov
Spacelabs Healthcare Inc.	Snoqualmie, WA, United States	34	35	0	70	api.fda.gov
Westmed, Inc.	Tucson, AZ, United States	46	35	0	5	api.fda.gov
Camber Spine Technologies	King of Prussia, PA, United States	34	34	0	0	api.fda.gov
Edwards Lifesciences LLC	Irvine, CA, United States	25	24	10	42	api.fda.gov
Kaz USA, Inc., A Helen of Troy Company	Marlborough, MA, United States	11	34	0	0	api.fda.gov
Oscor Inc.	Palm Harbor, FL, United States	14	33	1	10	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	23	34	0	8	api.fda.gov
Abbott Molecular, Inc.	Des Plaines, IL, United States	46	19	14	34	api.fda.gov
Carefusion	San Diego, CA, United States	7	33	0	3	api.fda.gov
Collagen Matrix, Inc	Allendale, NJ, United States	10	33	0	6	api.fda.gov
Exactech Sarasota	Sarasota, FL, United States	12	33	0	0	api.fda.gov
GE Healthcare Manufacturing LLC	Florence, SC, United States	4	33	0	0	api.fda.gov
Healgen Scientific LLC	Houston, TX, United States	77	33	0	1	api.fda.gov
ICU Medical, Inc.	Dublin, OH, United States	40	33	0	9	api.fda.gov
PENTAX of America, Inc.	Montvale, NJ, United States	36	33	0	26	api.fda.gov
Si-Bone, Inc.	Santa Clara, CA, United States	11	33	0	0	api.fda.gov
Sklar Corporation	Malvern, PA, United States	225	33	0	1	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	48	32	0	4	api.fda.gov
Covidien	Carlsbad, CA, United States	16	32	0	3	api.fda.gov
Global Protection Corp.	Lynn, MA, United States	7	31	1	1	api.fda.gov
Mexpo International, Inc.	Union City, CA, United States	7	32	0	0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	70	32	0	1	api.fda.gov
Medtronic Heart Valves Division	Santa Ana, CA, United States	12	22	10	8	api.fda.gov
Sysmex America, Inc.	Lincolnshire, IL, United States	30	32	0	9	api.fda.gov
Wilson-Cook Medical Inc.	Winston Salem, NC, United States	24	32	0	44	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	47	32	0	5	api.fda.gov
Arthrex Logistic Center	Fort Myers, FL, United States	31	31	0	0	api.fda.gov
Centrix, Inc.	Shelton, CT, United States	19	31	0	0	api.fda.gov
Cook Biotech, Inc.	West Lafayette, IN, United States	19	31	0	3	api.fda.gov
Diazyme Laboratories, Inc.	Poway, CA, United States	39	31	0	0	api.fda.gov
Kamiya Biomedical Company LLC	Tukwila, WA, United States	33	31	0	6	api.fda.gov
Lake Region Medical	Chaska, MN, United States	27	31	0	0	api.fda.gov
Nonin Medical, Inc.	Plymouth, MN, United States	7	31	0	4	api.fda.gov
Nvision Biomedical Technologies, Inc	San Antonio, TX, United States	29	31	0	0	api.fda.gov
Natus Medical Incorporated	San Diego, CA, United States	7	31	0	6	api.fda.gov
Ormco Corporation	Brea, CA, United States	37	31	0	0	api.fda.gov
Parcus Medical, L.L.C.	Sarasota, FL, United States	19	31	0	0	api.fda.gov
Reckitt Benckiser LLC	Nutley, NJ, United States	13	31	0	4	api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.	Minnetonka, MN, United States	15	28	3	13	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	31	31	0	1	api.fda.gov
Accriva Diagnostics, Inc.	San Diego, CA, United States	14	30	0	14	api.fda.gov
B. Braun Us Device Manufacturing LLC	Allentown, PA, United States	57	30	0	58	api.fda.gov
Dornier Medtech America, Inc.	Kennesaw, GA, United States	19	30	0	1	api.fda.gov
Ethicon, LLC	Guaynabo, PR, United States	16	29	1	2	api.fda.gov
GE Medical Systems Information Technologies, Inc.	Wauwatosa, WI, United States	40	30	0	6	api.fda.gov
Hu-Friedy MFG. Co. LLC	Northbrook, IL, United States	74	30	0	3	api.fda.gov
Ormco Corporation	Pomona, CA, United States	32	30	0	0	api.fda.gov
Premier Dental Products Co.	Plymouth Meeting, PA, United States	101	30	0	3	api.fda.gov
Spectranetics Corp.	Colorado Springs, CO, United States	12	28	2	17	api.fda.gov
Spineology Inc.	Saint Paul, MN, United States	15	30	0	2	api.fda.gov
SW Technologies Inc.	Union City, CA, United States	8	30	0	0	api.fda.gov
Stryker Sustainability Solutions - Chandler	Chandler, AZ, United States	12	30	0	0	api.fda.gov
Terumo Cardiovascular Systems Corporation	Elkton, MD, United States	17	30	0	18	api.fda.gov
Abbott Medical	Minnetonka, MN, United States	22	20	9	0	api.fda.gov
Allergan Sales, LLC	Irvine, CA, United States	18	24	5	7	api.fda.gov
Arlington Scientific, Inc.	Springville, UT, United States	27	29	0	0	api.fda.gov
Alere San Diego, Inc.	San Diego, CA, United States	27	29	0	46	api.fda.gov
Astura Medical	Irving, TX, United States	19	29	0	0	api.fda.gov
DiaSorin Molecular LLC	Cypress, CA, United States	41	29	0	14	api.fda.gov
Fenwal, Inc.	Lake Zurich, IL, United States	26	29	0	6	api.fda.gov
Genesys Spine	Austin, TX, United States	26	29	0	4	api.fda.gov
Kaz USA, Inc., A Helen of Troy Company	Olive Branch, MS, United States	7	29	0	0	api.fda.gov
Lemaitre Vascular, Inc.	Burlington, MA, United States	19	29	0	23	api.fda.gov
LeMaitre Vascular Inc.	Billerica, MA, United States	19	29	0	0	api.fda.gov
Medtronic Vascular	Danvers, MA, United States	13	28	1	17	api.fda.gov
Si-Bone, Inc.	Santa Clara, CA, United States	9	29	0	1	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	14	29	0	5	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	22	29	0	1	api.fda.gov
Zoll Medical Corporation	Chelmsford, MA, United States	29	22	7	20	api.fda.gov
4web Inc.	Frisco, TX, United States	33	28	0	1	api.fda.gov
Abbott Diabetes Care Inc.	Alameda, CA, United States	16	26	2	23	api.fda.gov
Applied Medical Technology, Inc.	Brecksville, OH, United States	16	28	0	8	api.fda.gov
Abbott Medical	Plano, TX, United States	14	25	3	22	api.fda.gov
Covidien llc	Santa Clara, CA, United States	10	28	0	30	api.fda.gov
Diagnostic Group LLC	Eden Prairie, MN, United States	7	28	0	0	api.fda.gov
DIAMOND DIAGNOSTICS Inc	Holliston, MA, United States	33	28	0	0	api.fda.gov
Lumiquick Diagnostics, Inc.	Santa Clara, CA, United States	60	28	0	1	api.fda.gov
MHC Medical Products	Fairfield, OH, United States	15	28	0	1	api.fda.gov
Mick Radio-Nuclear Instruments, Inc.	Mount Vernon, NY, United States	4	28	0	1	api.fda.gov
Sound Technology Inc.	State College, PA, United States	5	28	0	0	api.fda.gov
Titan Spine, a Division of Medtronic	Milwaukee, WI, United States	30	28	0	0	api.fda.gov
Acon Laboratories, Inc.	San Diego, CA, United States	31	27	0	1	api.fda.gov
Arthrosurface, Inc.	W Bridgewater, MA, United States	18	27	0	2	api.fda.gov
Bionostics, Inc.	Devens, MA, United States	27	27	0	0	api.fda.gov
Beaver-Visitec International, Inc.	Waltham, MA, United States	54	25	2	37	api.fda.gov
CC Wellness LLC	Valencia, CA, United States	4	27	0	0	api.fda.gov
Cochlear Americas Warehouse	Centennial, CO, United States	13	22	5	0	api.fda.gov
Dental Technologies, Inc.	Lincolnwood, IL, United States	21	27	0	0	api.fda.gov
DENTSPLY IH Inc.	Waltham, MA, United States	5	27	0	1	api.fda.gov
Diasorin Inc.	Stillwater, MN, United States	46	27	0	39	api.fda.gov
Draeger Medical Systems, Inc.	Andover, MA, United States	41	27	0	13	api.fda.gov
GE Medical Systems Information Technologies, Inc.	Waukesha, WI, United States	40	27	0	4	api.fda.gov
Medline Industries, LP - SPT	Waukegan, IL, United States	65	27	0	8	api.fda.gov
MedSource Labs, LLC	Chanhassen, MN, United States	66	27	0	0	api.fda.gov
Salvin Dental Specialties, LLC	Charlotte, NC, United States	75	27	0	0	api.fda.gov
Salaera, LLC d.b.a Maxtec	Salt Lake City, UT, United States	19	27	0	0	api.fda.gov
Solventum US LLC	Brookings, SD, United States	25	27	0	0	api.fda.gov
Straumann Manufacturing, Inc.	Mansfield, TX, United States	10	27	0	0	api.fda.gov
Argon Medical Devices, Inc.	Wheeling, IL, United States	34	26	0	2	api.fda.gov
Ascensia Diabetes Care US Inc.	Valhalla, NY, United States	10	24	2	3	api.fda.gov
Ascensia Diabetes Care US Inc.	Parsippany, NJ, United States	10	24	2	0	api.fda.gov
Bausch & Lomb Incorporated	Clearwater, FL, United States	10	15	11	9	api.fda.gov
BioFire Diagnostics, LLC	Salt Lake City, UT, United States	22	26	0	35	api.fda.gov
Caldera Medical, Inc.	Westlake Village, CA, United States	8	26	0	0	api.fda.gov
Coloplast Manufacturing Us, LLC	Minneapolis, MN, United States	18	24	2	16	api.fda.gov
Evoqua Water Technologies LLC	Minneapolis, MN, United States	6	26	0	3	api.fda.gov
Fukuda Denshi Usa, Inc.	Redmond, WA, United States	18	26	0	1	api.fda.gov
Haywood Vocational Opportunities Inc.	Waynesville, NC, United States	18	26	0	0	api.fda.gov
Keystone Industries	Myerstown, PA, United States	50	26	0	0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	30	26	0	0	api.fda.gov
Medela LLC	Mchenry, IL, United States	19	26	0	12	api.fda.gov
Megadyne Medical Products, Inc.	Cincinnati, OH, United States	5	26	0	11	api.fda.gov
Medivators Inc	Conroe, TX, United States	18	26	0	0	api.fda.gov
Numed, Inc.	Hopkinton, NY, United States	12	25	1	4	api.fda.gov
Omni-Guide Holdings, Inc.	Billerica, MA, United States	4	26	0	2	api.fda.gov
Pac-Dent Inc.	Brea, CA, United States	84	26	0	0	api.fda.gov
Pride Mobility Products Corp.	Duryea, PA, United States	25	26	0	6	api.fda.gov
Pride Mobility Products Corp.	North Las Vegas, NV, United States	25	26	0	0	api.fda.gov
Pride Mobility Products Corporation	North Las Vegas, NV, United States	25	26	0	0	api.fda.gov
Abbott Point Of Care Inc.	Princeton, NJ, United States	22	25	0	42	api.fda.gov
Arrow International, LLC (subsidiary of Teleflex, Incorporated)	Chelmsford, MA, United States	11	25	0	4	api.fda.gov
Biomerica	Irvine, CA, United States	28	25	0	1	api.fda.gov
Cadwell Industries, Inc.	Kennewick, WA, United States	24	25	0	3	api.fda.gov
Datex-Ohmeda, Inc.	Waukesha, WI, United States	12	25	0	1	api.fda.gov
Hosmed Inc.	Doral, FL, United States	46	25	0	0	api.fda.gov
Medtec LLC	Orange City, IA, United States	11	25	0	11	api.fda.gov
Multi-Med, Inc.	Keene, NH, United States	7	25	0	2	api.fda.gov
Metro Optics of Austin, Inc.	Pflugerville, TX, United States	1	24	1	0	api.fda.gov
Nexxt Spine LLC	Noblesville, IN, United States	20	25	0	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	San Diego, CA, United States	20	25	0	0	api.fda.gov
PREAT Corporation	Santa Maria, CA, United States	15	25	0	9	api.fda.gov
Quidel Corp.	San Diego, CA, United States	23	25	0	10	api.fda.gov
Solta Medical, Inc.	Bothell, WA, United States	8	25	0	5	api.fda.gov
Terumo Cardiovascular Systems Corporation	Ann Arbor, MI, United States	14	25	0	146	api.fda.gov
The Daavlin Distributing Co.	Bryan, OH, United States	2	25	0	4	api.fda.gov
American Orthodontics	Sheboygan, WI, United States	35	24	0	0	api.fda.gov
Becton Dickinson Infusion Therapy Systems Inc.	Sandy, UT, United States	8	24	0	17	api.fda.gov
Deephealth	Somerville, MA, United States	5	24	0	0	api.fda.gov
Ethicon, Inc.	San Angelo, TX, United States	6	23	1	0	api.fda.gov
Irvine Biomedical. Inc.	Irvine, CA, United States	9	20	4	1	api.fda.gov
Ischemaview, Inc.	Golden, CO, United States	6	24	0	0	api.fda.gov
Kci Usa, Inc.	San Antonio, TX, United States	3	24	0	2	api.fda.gov
Kci Usa, Inc.	San Antonio, TX, United States	3	24	0	7	api.fda.gov
Mim Software Inc.	Cleveland, OH, United States	8	24	0	2	api.fda.gov
Nxstage Medical, Inc.	Lawrence, MA, United States	11	24	0	18	api.fda.gov
Natus Neurology Incorporated	Middleton, WI, United States	32	24	0	15	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, United States	21	24	0	1	api.fda.gov
OsteoCentric Technologies,Inc	Logan, UT, United States	12	24	0	0	api.fda.gov
R & D Batteries, Inc.	Burnsville, MN, United States	20	24	0	0	api.fda.gov
Rhythmlink International, LLC	Columbia, SC, United States	9	24	0	0	api.fda.gov
Sterilmed, Inc.	Plymouth, MN, United States	8	24	0	4	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	26	24	0	2	api.fda.gov
Utak Laboratories, Inc.	Valencia, CA, United States	3	24	0	1	api.fda.gov
Ventana Medical Systems, Inc.	Tucson, AZ, United States	55	10	14	19	api.fda.gov
Volcano Corporation	Rancho Cordova, CA, United States	11	24	0	18	api.fda.gov
Vy Spine, LLC	Bountiful, UT, United States	15	24	0	0	api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.