Data / Medical devices / United States / Biotronix Healthcare Industries Inc.

Biotronix Healthcare Industries Inc.: FDA-registered device maker in Orlando, FL, United States, 90 510(k) clearances

Name: Biotronix Healthcare Industries Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biotronix Healthcare Industries Inc. is registered with the FDA (registration 3010131137) in Orlando, FL, United States. It lists 170 device types. The FDA files 90 510(k) clearances under its listings, the newest dated March 24, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010131137
Address: 4700 Millenia Blvd Ste 500, Orlando, FL, United States, 32839
Owner or operator: Biotronix Healthcare Industries Inc. (10043487)
Roles: Repackager or relabeler
First device listed: February 20, 2013
Registered through: 2026
Brand names listed: 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml,, Bio-Chamber Spacer, BioGuard Slide Safety Winged Blood Collection Set, Biotornix Healthcare AV Fistula Needle Set, Biotornix Healthcare AV Safety Fistula Needle, Biotornix Healthcare Epidural Touhy Needle, Biotornix Healthcare Pencil Point Needle, Biotornix Healthcare Quincke Spinal Needle and more

Devices it lists

Device	Product code	Class	Role	Source
Absorbent, Carbon-Dioxide	CBL	1	Repackager or relabeler	accessdata.fda.gov
Absorber, Carbon-Dioxide	BSF	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Catheter	KGZ	1	Repackager or relabeler	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Airway, Nasopharyngeal	BTQ	1	Repackager or relabeler	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Repackager or relabeler	accessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.	GTY	1	Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Repackager or relabeler	accessdata.fda.gov
Appliance, Colostomy, Disposable	EZS	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Repackager or relabeler	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	1	Repackager or relabeler	accessdata.fda.gov
Bag, Reservoir	BTC	1	Repackager or relabeler	accessdata.fda.gov
Bag, Urinary, Ileostomy	EXH	1	Repackager or relabeler	accessdata.fda.gov
Bag, Urine Collecting, Ureterostomy	EXG	1	Repackager or relabeler	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Blade, Scalpel	GES	1	Repackager or relabeler	accessdata.fda.gov
Bottle, Collection And Trap, Breathing System (Uncalibrated)	CBC	2	Repackager or relabeler	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Repackager or relabeler	accessdata.fda.gov
Brush, Scrub, Operating-Room	GEC	1	Repackager or relabeler	accessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-Disposable	FBM	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Manipulator/Injector, Uterine	LKF	2	Repackager or relabeler	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Repackager or relabeler	accessdata.fda.gov
Cap, Surgical	FYF	1	Repackager or relabeler	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Balloon Type	GBA	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Continuous Irrigation	GBQ	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Eustachian, General & Plastic Surgery	GBY	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Hemodialysis, Non-Implanted	MPB	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Infusion	JCY	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Multiple Lumen	GBP	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Nasal, Oxygen	BZB	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Pediatric, General & Plastic Surgery	GBN	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Peritoneal	GBW	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Ventricular, General & Plastic Surgery	GBS	1	Repackager or relabeler	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Repackager or relabeler	accessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, Percutaneous	LOX	2	Repackager or relabeler	accessdata.fda.gov
Chamber, Slide Culture	KIY	1	Repackager or relabeler	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Vascular	DXC	2	Repackager or relabeler	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Repackager or relabeler	accessdata.fda.gov
Component, Cast	LGF	1	Repackager or relabeler	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Repackager or relabeler	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen Mailer And Storage, Sterile	KDT	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Repackager or relabeler	accessdata.fda.gov
Cotton, Roll	EFN	1	Repackager or relabeler	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Repackager or relabeler	accessdata.fda.gov
Coverslips, Microscope Slide	KES	1	Repackager or relabeler	accessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)	HHK	2	Repackager or relabeler	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Repackager or relabeler	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Repackager or relabeler	accessdata.fda.gov
Device, Percutaneous, Biopsy	MJG	1	Repackager or relabeler	accessdata.fda.gov
Device, Rebreathing	BYW	1	Repackager or relabeler	accessdata.fda.gov
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	FFG	2	Repackager or relabeler	accessdata.fda.gov
Dilator, Cervical, Fixed Size	HDQ	1	Repackager or relabeler	accessdata.fda.gov
Dilator, Vaginal	HDX	2	Repackager or relabeler	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Repackager or relabeler	accessdata.fda.gov
Electrode, Electrocardiograph, Multi-Function	MLN	2	Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
Enema Kit	FCE	1	Repackager or relabeler	accessdata.fda.gov
Enteral Syringes With Enteral Specific Connectors	PNR	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Repackager or relabeler	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Repackager or relabeler	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Repackager or relabeler	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Repackager or relabeler	accessdata.fda.gov
Film, Radiographic	IWZ	1	Repackager or relabeler	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Repackager or relabeler	accessdata.fda.gov
Flask, Tissue Culture	KJA	1	Repackager or relabeler	accessdata.fda.gov
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	CCN	1	Repackager or relabeler	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Repackager or relabeler	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Repackager or relabeler	accessdata.fda.gov
Gown, Examination	FME	1	Repackager or relabeler	accessdata.fda.gov
Gown, Surgical	FYA	2	Repackager or relabeler	accessdata.fda.gov
Holding Chambers, Direct Patient Interface	NVP	2	Repackager or relabeler	accessdata.fda.gov
I.V. Start Kit	LRS	2	Repackager or relabeler	accessdata.fda.gov
Illuminator, Radiographic-Film	IXC	1	Repackager or relabeler	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Specialized Obstetric-Gynecologic	KNA	2	Repackager or relabeler	accessdata.fda.gov
Introducer, Catheter	DYB	2	Repackager or relabeler	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Repackager or relabeler	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Repackager or relabeler	accessdata.fda.gov
Latex Patient Examination Glove	LYY	1	Repackager or relabeler	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Repackager or relabeler	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen	BYG	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen, Low Concentration, Venturi	BYF	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Repackager or relabeler	accessdata.fda.gov
Mask, Surgical	FXX	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Repackager or relabeler	accessdata.fda.gov
Micro Pipette	JRC	1	Repackager or relabeler	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Repackager or relabeler	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Repackager or relabeler	accessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	1	Repackager or relabeler	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Repackager or relabeler	accessdata.fda.gov
Needle, Fistula	FIE	2	Repackager or relabeler	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Repackager or relabeler	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Repackager or relabeler	accessdata.fda.gov
Needle, Suturing, Reusable	GDL	1	Repackager or relabeler	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Repackager or relabeler	accessdata.fda.gov
Pessary, Vaginal	HHW	2	Repackager or relabeler	accessdata.fda.gov
Pipette, Diluting	GGY	1	Repackager or relabeler	accessdata.fda.gov
Pipette, Quantitative, Hematology	GJG	1	Repackager or relabeler	accessdata.fda.gov
Pipette, Sahli	GGX	1	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Pouch, Colostomy	EZQ	1	Repackager or relabeler	accessdata.fda.gov
Razor, Surgical	LWK	1	Repackager or relabeler	accessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-Type	HHF	1	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Repackager or relabeler	accessdata.fda.gov
Slides, Microscope	KEW	1	Repackager or relabeler	accessdata.fda.gov
Sound, Uterine	HHM	1	Repackager or relabeler	accessdata.fda.gov
Spinner System, Cell Culture	KJE	1	Repackager or relabeler	accessdata.fda.gov
Spinner, Flask	KJD	1	Repackager or relabeler	accessdata.fda.gov
Staple, Implantable	GDW	2	Repackager or relabeler	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Repackager or relabeler	accessdata.fda.gov
Stapler, Surgical	GAG	2	Repackager or relabeler	accessdata.fda.gov
Stent, Ureteral	FAD	2	Repackager or relabeler	accessdata.fda.gov
Stethoscope, Esophageal	BZW	1	Repackager or relabeler	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	1	Repackager or relabeler	accessdata.fda.gov
Stylet, Ureteral	EYA	1	Repackager or relabeler	accessdata.fda.gov
Surgeon'S Gloves	KGO	1	Repackager or relabeler	accessdata.fda.gov
Suture Removal Kit	MCZ	1	Repackager or relabeler	accessdata.fda.gov
Suture, Absorbable, Natural	GAL	2	Repackager or relabeler	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Repackager or relabeler	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Antistick	MEG	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Repackager or relabeler	accessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	EYZ	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tent, Oxygen	BYL	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Repackager or relabeler	accessdata.fda.gov
Tracheostomy And Nasal Suctioning Kit	LRQ	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Repackager or relabeler	accessdata.fda.gov
Tube, Feeding	FPD	2	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	2	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)	BTO	2	Repackager or relabeler	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Repackager or relabeler	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Repackager or relabeler	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Repackager or relabeler	accessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling Catheter	FCN	2	Repackager or relabeler	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Repackager or relabeler	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 24, 2023	K223323	Blood Collection Needle (with/without Needle Holder)	JKA	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
November 4, 2022	K222124	Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle	FMI	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
October 28, 2022	K221521	Disposable Safety Lancet	FMK	Substantially Equivalent	SteriLance Medical (Suzhou), Inc.	accessdata.fda.gov
October 21, 2022	K222141	Safety Blood Collection Needle (Without Needle Holder)	JKA	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
April 12, 2022	K214075	Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)	FMI	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
October 18, 2021	K211555	Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe	MEG	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
August 26, 2021	K210745	Heel Incision Safety Lancet	FMK	Substantially Equivalent	SteriLance Medical (Suzhou), Inc.	accessdata.fda.gov
December 15, 2020	K202698	Prefilled Syringe	EZL	Substantially Equivalent	Hangzhou Primecare Medical Co., Ltd.	accessdata.fda.gov
September 9, 2020	K200027	Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter	JKA	Substantially Equivalent	Jiangsu Caina Medical Co.,Ltd	accessdata.fda.gov
April 23, 2020	K192230	MF SAFECATH	FOZ	Substantially Equivalent	Medifirst Co., Ltd.	accessdata.fda.gov
October 4, 2019	K190183	Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe	MEG	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
January 16, 2019	K173847	Disposable Ultra Reinforced Surgical Gown	FYA	Substantially Equivalent	Xiantao Rayxin Medical Products Co., Ltd.	accessdata.fda.gov
July 12, 2018	K181276	CONOD Enteral Feeding Sets	PIF	Substantially Equivalent	Conod Medical Co., Limited	accessdata.fda.gov
June 4, 2018	K172763	Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder	JKA	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov
September 22, 2016	K162188	Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)	PNR	Substantially Equivalent	Vr Medical Technology	accessdata.fda.gov
June 15, 2016	K153496	Disposable Surgical Face Mask	FXX	Substantially Equivalent	Xiantao Rayxin Medical Products Co., Ltd.	accessdata.fda.gov
June 18, 2015	K142797	I.V. Catheter	FOZ	Substantially Equivalent	Jiangxi Sanxin Medtec Co., Ltd.	accessdata.fda.gov
March 20, 2015	K140356	SUMMED HIGH PRESSURE LINE	DQO	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.	accessdata.fda.gov
January 8, 2015	K140237	DISPOSABLE NEBULIZER SET	CAF	Substantially Equivalent	Suzhou Weikang Medical Apparatus Co., Ltd.	accessdata.fda.gov
December 12, 2014	K133795	SUMMED INFLATION DEVICE KIT	MAV	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.	accessdata.fda.gov
July 30, 2014	K132709	VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER	CAH	Substantially Equivalent	Vr Medical	accessdata.fda.gov
February 25, 2014	K133058	INSULIN PEN NEEDLE	FMI	Substantially Equivalent	Wenzhou Wuzhou Import & Export Co., Ltd.	accessdata.fda.gov
February 3, 2014	K123475	SHOOCIN INTRODUCER KIT	DYB	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
January 31, 2014	K133343	WONDFO RAPID STREP A TEST	GTY	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
January 14, 2014	K130737	SYNTHETIC ABSORBABLE SUTURE	GAM	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
January 14, 2014	K130735	SYNTHETIC ABSORBABLE SUTURE	GAM	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
January 10, 2014	K130087	PANPAC WORD/BARTHOLIN CATHETER	KNA	Substantially Equivalent	Panpac Medical Corporation	accessdata.fda.gov
December 19, 2013	K123030	COMPRESSOR NEBULIZER MODEL MCN-S600XX	CAF	Substantially Equivalent	Dongguan Aidisy Machinery & Electronic Equipment C	accessdata.fda.gov
August 13, 2013	K123473	HOPER PTCA BALLOON CATHETER	LOX	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
August 8, 2013	K130273	PANPAC VAGINAL DILATORS	HDX	Substantially Equivalent	Panpac Medical Corporation	accessdata.fda.gov
July 31, 2013	K131754	WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)	DIO	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
July 5, 2013	K131511	DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR	GDW	Substantially Equivalent	Changzhou Sinolinks Medical Innovation Co., Ltd.	accessdata.fda.gov
December 21, 2012	K120475	ANESTHESIA CONDUCTION NEEDLES	BSP	Substantially Equivalent	Shanghai Samedical & Plastic Instruments Co., Ltd.	accessdata.fda.gov
July 16, 2012	K121474	DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER	GDW	Substantially Equivalent	Changzhou Kangdi Medical Stapler Co., Ltd.	accessdata.fda.gov
May 11, 2012	K120119	SUNMED GUIDE WIRE	DQX	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.	accessdata.fda.gov
December 15, 2011	K102898	BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE	LKF	Substantially Equivalent	Panpac Medical Corporation	accessdata.fda.gov
December 14, 2011	K112057	KDL SYRINGES AND NEEDLE	FMF	Substantially Equivalent	Shanghai Kindly Enterprise Dev. Group Co.,	accessdata.fda.gov
November 18, 2011	K102833	DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS	MPB	Substantially Equivalent	Foshan Nanhai Bai HE Medical Technology Co., Ltd.	accessdata.fda.gov
October 7, 2011	K102316	GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM	CGA	Substantially Equivalent	Broadmaster Biotech Corporation	accessdata.fda.gov
September 27, 2011	K111837	RADIAL ARTERY COMPRESSION TOURNIQUET	DXC	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
September 16, 2011	K111559	SURGICAL MASKS	FXX	Substantially Equivalent	Shanghai Neo-Medical Import & Export Co., Ltd.	accessdata.fda.gov
August 26, 2011	K110269	WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL	BTR	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
May 20, 2011	K110182	CANNABINOIDS URINE TEST	LDJ	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
May 13, 2011	K110853	VR MEDICAL ENTERAL ORAL SYRINGE	FPD	Substantially Equivalent	Vr Medical	accessdata.fda.gov
April 26, 2011	K110421	DISPOSABLE INSULIN SYRINGE	FMF	Substantially Equivalent	Wenzhou Wuzhou Import & Export Co., Ltd.	accessdata.fda.gov
January 28, 2011	K101136	FISIO CHAMBER SPACE	NVP	Substantially Equivalent	Koo (Shanghai) Industries Co., Ltd.	accessdata.fda.gov
November 3, 2010	K102372	OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB	GEI	Substantially Equivalent	Jiangmen City Xinhui Baisheng Medical Equipment CO	accessdata.fda.gov
July 26, 2010	K092982	THE PANPAC SUCTION CURETTE	HHK	Substantially Equivalent	Panpac Medical Corporation	accessdata.fda.gov
July 22, 2010	K092981	PANPAC VAGINAL PESSARY	HHW	Substantially Equivalent	Panpac Medical Corporation	accessdata.fda.gov
July 12, 2010	K093910	IMPROVACUTER GEL & CLOT ACTIVATOR TUBE	JKA	Substantially Equivalent	Guangzhou Improve Medical Instruments Co., Ltd.	accessdata.fda.gov
June 7, 2010	K092983	PANPAC HSG CATHETER SET	LKF	Substantially Equivalent	Panpac Medical Corporation	accessdata.fda.gov
April 30, 2010	K100723	DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5	GDW	Substantially Equivalent	Changzhou Kangdi Medical Stapler Co., Ltd.	accessdata.fda.gov
April 7, 2010	K092984	PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0	LKF	Substantially Equivalent	Panpac Medical Corporation	accessdata.fda.gov
March 11, 2010	K092980	PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5	LKF	Substantially Equivalent	Panpac Medical Corporation	accessdata.fda.gov
March 11, 2010	K092886	WELL LEAD ENDOBRONCHIAL TUBES	CBI	Substantially Equivalent	Well Lead Instruments	accessdata.fda.gov
December 1, 2009	K092634	OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF	GEI	Substantially Equivalent	Jiangmen City Xinhui Baisheng Medical Equipment CO	accessdata.fda.gov
October 16, 2009	K091516	WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR	EZL	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
August 7, 2009	K083429	I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT	FOZ	Substantially Equivalent	Weihai Jierui Medical Products Co., Ltd.	accessdata.fda.gov
June 11, 2009	K083687	BAIXIN INTRAVASCULAR ADMINISTRATION SET	FPA	Substantially Equivalent	Anhui Kangda Medical Products Co., Ltd.	accessdata.fda.gov
March 23, 2009	K082439	DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT	DXT	Substantially Equivalent	Shandong Weigao Medical Polymer Co., Ltd.	accessdata.fda.gov
October 8, 2008	K082815	WELL LEAD SILICONE AND LATEX FOLEY CATHETERS	EZL	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
July 10, 2008	K073383	WELL LEAD REINFORCED ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
June 9, 2008	K080684	WG-SURGICAL SUTURES WITH NEEDLE	GAP	Substantially Equivalent	Foosin Medical Supplies, Inc.	accessdata.fda.gov
April 30, 2008	K073614	WG-SURGICAL SUTURES WITH NEEDLE	NEW	Substantially Equivalent	Foosin Medical Supplies, Inc.	accessdata.fda.gov
March 21, 2008	K072739	JIERUI SYRINGES AND NEEDLES	MEG	Substantially Equivalent	Shandong Weigao Group Medical Polymer Co., Ltd.	accessdata.fda.gov
December 20, 2007	K073127	BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G	FMI	Substantially Equivalent	Shandong Weigao Group Medical Polymer Co., Ltd.	accessdata.fda.gov
July 31, 2007	K070451	ABLE CENTRAL VENOUS CATHETER	FOZ	Substantially Equivalent	Foshan Nanhai Bai HE Medical Technology Co., Ltd.	accessdata.fda.gov
July 26, 2006	K060018	TRULENE MESH	FTL	Substantially Equivalent	Sutures India Pvt., Ltd.	accessdata.fda.gov
July 18, 2006	K053236	DAVID PREGNANCY TEST (MIDSTREAM)	LCX	Substantially Equivalent	Runbio Biotech Co.,Ltd	accessdata.fda.gov
February 10, 2006	K060211	WUZHOU SYRINGE, WITH/WITHOUT NEEDLE	FMF	Substantially Equivalent	Wenzhou Wuzhou Group Co. , Ltd.	accessdata.fda.gov
April 8, 2005	K043443	ONE STEP HCG URINE PREGNANCY TEST	LCX	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
February 18, 2005	K042683	WELL LEAD ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
February 17, 2005	K042684	WELL LEAD TRACHEOSTOMY TUBE	BTO	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
December 30, 2004	K033210	BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET	FAD	Substantially Equivalent	Bioteque Corp.	accessdata.fda.gov
March 22, 2004	K032292	BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX	FOZ	Substantially Equivalent	Bioteque Corp.	accessdata.fda.gov
February 24, 2004	K040176	MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES	LZA	Substantially Equivalent	Maxter Glove Manufacturing Sdn Bhd	accessdata.fda.gov
October 17, 2003	K032501	MAXTER STERILE POWDER FREE SURGICAL GLOVES	KGO	Substantially Equivalent	Maxter Glove Manufacturing Sdn Bhd	accessdata.fda.gov
October 10, 2003	K032467	MAXTER STERILE POWDERED LATEX SURGICAL GLOVES	KGO	Substantially Equivalent	Maxter Glove Manufacturing Sdn Bhd	accessdata.fda.gov
October 9, 2002	K022666	PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.	NEW	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
September 10, 2002	K022664	PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.	GAM	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
January 17, 2002	K013498	CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)	LYY	Substantially Equivalent	Maxter Glove Manufacturing Sdn Bhd	accessdata.fda.gov
November 29, 2001	K013443	POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2	LYY	Substantially Equivalent	Maxter Glove Manufacturing Sdn Bhd	accessdata.fda.gov
December 21, 2000	K000714	VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET	FMI	Substantially Equivalent	Med-Pro Technologies, Inc.	accessdata.fda.gov
April 28, 2000	K000542	PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP	GAL	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
April 28, 2000	K000541	SILK NONABSORBABLE SURGICAL SUTURES, USP	GAP	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
April 27, 2000	K000540	POLYESTER NONABSORBABLE SURGICAL SUTURES, USP	GAT	Substantially Equivalent for Some Indications	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
April 27, 2000	K000539	NYLON NONABSORBABLE SURGICAL SUTURES, USP	GAR	Substantially Equivalent for Some Indications	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
April 27, 2000	K000537	POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP	GAW	Substantially Equivalent for Some Indications	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
March 30, 2000	K000369	VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER	FMI	Substantially Equivalent	Medpro Technologies, Inc.	accessdata.fda.gov
December 17, 1999	K993118	BIOTEQUE A.V. FISTULA NEEDLE SET	FIE	Substantially Equivalent	Bioteque Corp.	accessdata.fda.gov

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Updated March 24, 2023. 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.