Data / FDA device clearances / General Hospital

FDA General Hospital device clearances: 378 since Nov 2024

Name: FDA general hospital device clearances and approvals
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA general hospital device clearances and approvals: 378 rows for $18.90, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 13 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/panel/general-hospital, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 378 device decisions in general hospital (FDA review panel) from November 12, 2024 to October 30, 2026: 339 510(k) clearances and De Novo grants and 39 PMA approvals and supplements, for 230 applicants. The newest, P860004/S465 on October 30, 2026, is SynchroMed Infusion System, Ascenda Intrathecal Catheters from Medtronic, Inc..

The request: Every new FDA clearance or approval of a general hospital device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.

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378Decisions
339510(k) and De Novo
39PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 378, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision date	Number	Device	Applicant	Location	Decision	Type	Product code	Source
October 30, 2026	P860004/S465	SynchroMed Infusion System, Ascenda Intrathecal Catheters	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
October 30, 2026	K260354	Foster Plus-22L (SNK/CE-F22)	Zhejiang Fomos Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FLE	accessdata.fda.gov
October 29, 2026	P860004/S464	SynchroMed Infusion System, Ascenda Intrathecal Catheters TDD (Drug Delivery Infusion Pump 8667), TDD (Drug...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
October 29, 2026	K263530	V-Pro maX 2 Low Temperature Sterilization System	Steris	Ohio	Substantially Equivalent	510(k) special	MLR	accessdata.fda.gov
October 29, 2026	K260427	Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+)	Lumicare Medtech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	SCS	accessdata.fda.gov
October 29, 2026	K253508	Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile	Vietglove Corporation	Vietnam	Substantially Equivalent	510(k) traditional	LZA	accessdata.fda.gov
October 28, 2026	K260822	VERIFY RESI-TEST SWAB Protein Detection Indicator	Steris	Ohio	Substantially Equivalent	510(k) traditional	SDC	accessdata.fda.gov
October 27, 2026	P860004/S458	SynchroMed Infusion System, Ascenda Intrathecal Catheters	Medtronic, Inc.	Minnesota	Approved	PMA 180-day supplement	LKK	accessdata.fda.gov
October 22, 2026	K262084	S.I.N. Instruments Kits	S.I.N. Implant System Ltda	Brazil	Substantially Equivalent	510(k) traditional	KCT	accessdata.fda.gov
October 22, 2026	K260261	Gravity Blood Sets with 200µm Filter	B.Braun Medical, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	FPA	accessdata.fda.gov
October 16, 2026	P860004/S462	SynchroMed Infusion System, Ascenda Intrathecal Catheters	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
October 16, 2026	K263267	Endox Test Strips	Ibt Scientific	North Carolina	Substantially Equivalent	510(k) traditional	JOJ	accessdata.fda.gov
October 16, 2026	K260180	Carecube Negative Pressure Isolation Chamber (1BY)	Carecubes, Inc.	California	Substantially Equivalent	510(k) traditional	LGM	accessdata.fda.gov
October 16, 2026	K254094	Endox High Level Disinfectant	Whiteley USA, Inc.	Delaware	Substantially Equivalent	510(k) traditional	MED	accessdata.fda.gov
October 14, 2026	K262042	Sterilization Cassette (CASS-1)	Alliedstar Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) traditional	KCT	accessdata.fda.gov
October 9, 2026	K260080	Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler	Medical Components, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	LJS	accessdata.fda.gov
October 6, 2026	K262516	TSK OptiXion	Tsk Laboratory, Japan	Japan	Substantially Equivalent	510(k) traditional	QYM	accessdata.fda.gov
October 1, 2026	K262208	Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use...	Yty Industry (Manjung) Sdn Bhd	Malaysia	Substantially Equivalent	510(k) traditional	LZA	accessdata.fda.gov
September 25, 2026	K261992	3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)	Solventum US, LLC	Texas	Substantially Equivalent	510(k) traditional	JOJ	accessdata.fda.gov
September 18, 2026	K262532	NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)	ICU Medical	Illinois	Substantially Equivalent	510(k) traditional	LGZ	accessdata.fda.gov
September 18, 2026	K254095	25G Huber Needle	Martech Medical Products	Pennsylvania	Substantially Equivalent	510(k) traditional	PTI	accessdata.fda.gov
September 17, 2026	K261266	MOWANA Auto Duo	Pentamaster Mediq Sdn Bhd	Malaysia	Substantially Equivalent	510(k) traditional	FMI	accessdata.fda.gov
September 11, 2026	K254123	Ecomed Disposable Administration Sets	Ecomed Solutions, LLC	Illinois	Substantially Equivalent	510(k) abbreviated	FPA	accessdata.fda.gov
September 9, 2026	K262542	Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination...	Top Glove Sdn. Bhd.	Malaysia	Substantially Equivalent	510(k) special	LZA	accessdata.fda.gov
September 9, 2026	K261793	Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and...	Maxter Healthcare, Inc.	Texas	Substantially Equivalent	510(k) traditional	LZA	accessdata.fda.gov
September 8, 2026	K260312	Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation...	Gmp Medicare Sdn. Bhd.	Malaysia	Substantially Equivalent	510(k) special	LZA	accessdata.fda.gov
September 8, 2026	K253988	LiteSet Trays	Nobel Biocare AB	Sweden	Substantially Equivalent	510(k) traditional	KCT	accessdata.fda.gov
September 4, 2026	K261935	Surgical and Prosthetic Trays	Dentsply Sirona, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	KCT	accessdata.fda.gov
September 2, 2026	K262153	Pivot Insulin Delivery System	Modular Medical, Inc.	California	Substantially Equivalent	510(k) traditional	LZG	accessdata.fda.gov
September 2, 2026	K261749	Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	Cardinalhealth	Illinois	Substantially Equivalent	510(k) traditional	LZA	accessdata.fda.gov
September 2, 2026	K260432	Ruby Intravascular Catheter	Venocare, Inc.	Florida	Substantially Equivalent	510(k) traditional	FOZ	accessdata.fda.gov
August 31, 2026	K261403	Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter	Global Life Sciences Solutions USA, LLC	Massachusetts	Substantially Equivalent	510(k) traditional	FPB	accessdata.fda.gov
August 26, 2026	K262581	GraftGun Universal Graft Delivery System (GDS®)	SurGenTec, LLC	Florida	Substantially Equivalent	510(k) special	FMF	accessdata.fda.gov
August 25, 2026	K261719	Promisemed X-Safety Pen Needle	Promisemed Hangzhou Meditech Co., Ltd.	China	Substantially Equivalent	510(k) special	FMI	accessdata.fda.gov
August 25, 2026	K252184	SOL-M Luer Lock Syringe with Exchangeable Needle Tray	Sol-Millennium Medical, Inc.	Illinois	Substantially Equivalent	510(k) traditional	FMF	accessdata.fda.gov
August 21, 2026	P860004/S461	SynchroMed III Pump Drug Delivery Infusion Pump	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
August 19, 2026	DEN250046	Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)	Vitestro	Netherlands	Unknown	De Novo	SIW	accessdata.fda.gov
August 18, 2026	K260794	NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR...	Kossan International Sdn Bhd	Malaysia	Substantially Equivalent	510(k) traditional	LZA	accessdata.fda.gov
August 14, 2026	K253747	Disposable Pen Injector (KXYC-03C02, KXYC-03A03)	Jiangsu Enjosim Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FMF	accessdata.fda.gov
August 13, 2026	P860004/S460	SynchroMed Infusion System, Ascenda Intrathecal Catheters	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
August 10, 2026	K262427	Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety...	Hh Global Technology, Inc.	Georgia	Substantially Equivalent	510(k) special	FMI	accessdata.fda.gov
August 10, 2026	K260165	Unimpregnated Central Venous Catheter	Spectrum Vascular	New York	Substantially Equivalent	510(k) traditional	FOZ	accessdata.fda.gov
August 8, 2026	P860004/S459	SynchroMed Infusion System; Ascenda Intrathecal Catheters	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
August 7, 2026	K260933	Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R...	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FMI	accessdata.fda.gov
August 5, 2026	K260845	Huahong Sharps Container (HHR-I, HHR-II)	Tianjin Huahong Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MMK	accessdata.fda.gov
August 4, 2026	K253760	OMNI Ultra Surgical System (1-110)	Sight Sciences, Inc.	California	Substantially Equivalent	510(k) traditional	MRH	accessdata.fda.gov
July 29, 2026	K261829	Profoject Dual-Safety Pen Needles	CMT Health PTE., Ltd.	Singapore	Substantially Equivalent	510(k) traditional	FMI	accessdata.fda.gov
July 28, 2026	K260326	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)	Datex-Ohmeda, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	FMZ	accessdata.fda.gov
July 24, 2026	K253703	RemunityPRO+ Pump for Remodulin® (treprostinil) Injection	Deka R&D Corp	New Hampshire	Substantially Equivalent	510(k) traditional	FRN	accessdata.fda.gov
July 21, 2026	K262014	PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves	O&M Halyard, Inc.	Georgia	Substantially Equivalent	510(k) special	LZA	accessdata.fda.gov
July 20, 2026	K254285	Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder...	Hartalega NGC Sdn. Bhd.	Malaysia	Substantially Equivalent	510(k) special	LZA	accessdata.fda.gov
July 15, 2026	K260739	Profoject Pen Needles (Model A; Model B)	CMT Health PTE., Ltd.	Singapore	Substantially Equivalent	510(k) traditional	FMI	accessdata.fda.gov
July 13, 2026	K260208	Ultra-Fine SAFETY Insulin Syringe	embecta Medical II, LLC	New Jersey	Substantially Equivalent	510(k) traditional	FMF	accessdata.fda.gov
July 10, 2026	K261041	ClearSafe Closed System	MedSource Labs, LLC	Minnesota	Substantially Equivalent	510(k) traditional	FOZ	accessdata.fda.gov
July 9, 2026	K260539	MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter	MedSource Labs, LLC	Minnesota	Substantially Equivalent	510(k) traditional	FOZ	accessdata.fda.gov
July 2, 2026	K261897	HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap...	O&M Halyard, Inc.	Georgia	Substantially Equivalent	510(k) traditional	FRG	accessdata.fda.gov
July 1, 2026	K253527	Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload...	Covidien, LLC	Connecticut	Substantially Equivalent	510(k) traditional	GAG	accessdata.fda.gov
June 24, 2026	K261055	AMSCO 700 Steam Sterilizer	STERIS Corporation	Ohio	Substantially Equivalent	510(k) traditional	FLE	accessdata.fda.gov
June 24, 2026	K252117	Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs...	Sw Technologies, Inc.	California	Substantially Equivalent	510(k) special	LZA	accessdata.fda.gov
June 18, 2026	K253824	Powder Free Nitrile Examination Gloves Non-Sterile Black	Kanglongda Vietnam Protection Technology Company Limited	Vietnam	Substantially Equivalent	510(k) traditional	LZA	accessdata.fda.gov
June 18, 2026	K253187	SteriBest® Sterilization Tray System	Mastel Surgical	South Dakota	Substantially Equivalent	510(k) traditional	KCT	accessdata.fda.gov
June 18, 2026	K253110	Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe	Sol-Millennium Medical, Inc.	Illinois	Substantially Equivalent	510(k) traditional	FMF	accessdata.fda.gov
June 18, 2026	K251559	InstaTRU Instant Biological Indicator for Steam (IBI-05)	True Indicating, LLC	Ohio	Substantially Equivalent	510(k) traditional	QVB	accessdata.fda.gov
June 17, 2026	K260916	FLEXI-PORT Power Injectable Implantable Port	Portal Access, Inc.	Florida	Substantially Equivalent	510(k) traditional	LJT	accessdata.fda.gov
June 17, 2026	K260867	Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)...	Hartalega NGC Sdn. Bhd.	Malaysia	Substantially Equivalent	510(k) special	LZA	accessdata.fda.gov
June 12, 2026	K260514	Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with...	CMT Health PTE., Ltd.	Singapore	Substantially Equivalent	510(k) traditional	FMF	accessdata.fda.gov
June 12, 2026	K253688	MEDRAD® Imaging Bulk Package Transfer Spike	Bayer Medical Care, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	PQH	accessdata.fda.gov
June 12, 2026	K252987	ADRx Admixture Device	Epic Medical Pte. , Ltd.	Singapore	Substantially Equivalent	510(k) traditional	LHI	accessdata.fda.gov
June 10, 2026	K260855	Profoject Safety Pen Needles	CMT Health PTE., Ltd.	Singapore	Substantially Equivalent	510(k) traditional	FMI	accessdata.fda.gov
June 5, 2026	K260301	Vial Adapter	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	LHI	accessdata.fda.gov
June 5, 2026	K253162	Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes...	Unimed Medical Supplies, Inc.	China	Substantially Equivalent	510(k) traditional	FLL	accessdata.fda.gov
June 3, 2026	K261530	iiSure Infusion Set	Deka Research and Development	New Hampshire	Substantially Equivalent	510(k) special	FPA	accessdata.fda.gov
June 3, 2026	K260806	Nitrile Disposable Examination Gloves	Vista Industries,, LLC	California	Substantially Equivalent	510(k) traditional	LZA	accessdata.fda.gov
June 3, 2026	K260726	Straumann® ProClean Cassette (041.800 ; 041.801)	Institut Straumann AG	Switzerland	Substantially Equivalent	510(k) traditional	KCT	accessdata.fda.gov
June 3, 2026	K260703	Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free...	S&S Glove Corporation	Vietnam	Substantially Equivalent	510(k) traditional	LZA	accessdata.fda.gov
June 3, 2026	K252854	SteriTite Container System with MediTray Products	Case Medical, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	KCT	accessdata.fda.gov
May 28, 2026	K252823	Dukal Crepe Paper Sterilization Wrap	Dukal, LLC	New York	Substantially Equivalent	510(k) traditional	FRG	accessdata.fda.gov
May 22, 2026	K253773	Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA)...	Taizhou Huangyan Guanhong Plastic Steel Products Factory	China	Substantially Equivalent	510(k) traditional	MMK	accessdata.fda.gov
May 21, 2026	K253112	Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter...	Hlb Lifescience Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	FMF	accessdata.fda.gov
May 18, 2026	K253454	HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL...	O&M Halyard, Inc.	Georgia	Substantially Equivalent	510(k) traditional	FRG	accessdata.fda.gov
May 15, 2026	K253235	Introcan Safety® Deep Access XL IV Catheter	B.Braun Medical, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	FOZ	accessdata.fda.gov
May 4, 2026	K252543	AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF...	Amsino International, Inc.	California	Substantially Equivalent	510(k) traditional	FPA	accessdata.fda.gov
May 1, 2026	DEN240075	Prolystica Pass Thru Disinfectant Wipes	Steris	Ohio	Unknown	De Novo	SHM	accessdata.fda.gov
April 30, 2026	K250680	Bayesian Health Sepsis Flagging Device	Bayesian Health, Inc.	New York	Substantially Equivalent	510(k) traditional	SAK	accessdata.fda.gov
April 29, 2026	K252471	Paptizer 360	LiViliti Health Products Corporation	Florida	Substantially Equivalent	510(k) traditional	QXQ	accessdata.fda.gov
April 24, 2026	K260988	°M Warmer System with °M Station	Mequ A/S	Denmark	Substantially Equivalent	510(k) special	LGZ	accessdata.fda.gov
April 24, 2026	K250234	SMARTeZ Elastomeric Infusion Pump (RS series)	Epic Medical Pte. , Ltd.	Singapore	Substantially Equivalent	510(k) traditional	MEB	accessdata.fda.gov
April 22, 2026	K252306	Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD)...	Steritec Products	Colorado	Substantially Equivalent	510(k) traditional	QVB	accessdata.fda.gov
April 20, 2026	K253558	Luminoah FLOW Enteral Nutrition System	Luminoah	Virginia	Substantially Equivalent	510(k) traditional	LZH	accessdata.fda.gov
April 17, 2026	K260929	Neonav ECG Tip Location System	Navi Medical Technologies	Australia	Substantially Equivalent	510(k) special	LJS	accessdata.fda.gov
April 17, 2026	K252279	Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)	Chirana T.Injecta,A.S.	Slovakia	Substantially Equivalent	510(k) traditional	FMF	accessdata.fda.gov
April 16, 2026	K254273	Verisafe Safety Sterile Needles (SSN)	Promisemed Hangzhou Meditech Co., Ltd.	China	Substantially Equivalent	510(k) special	FMI	accessdata.fda.gov
April 15, 2026	K252843	STERRAD 100NX Sterilization System with ALLClear Technology (10104)	Advanced Sterilization Products, Inc.	California	Substantially Equivalent	510(k) traditional	MLR	accessdata.fda.gov
April 10, 2026	K252757	CeQur Simplicity On-Demand Insulin Delivery System	Cequr SA	Switzerland	Substantially Equivalent	510(k) special	OPP	accessdata.fda.gov
April 8, 2026	K260766	Celerity 5 HP Biological Indicator (LCB052)	STERIS Corporation	Ohio	Substantially Equivalent	510(k) special	FRC	accessdata.fda.gov
April 8, 2026	K253534	Pivot Insulin Delivery System	Modular Medical	California	Substantially Equivalent	510(k) traditional	LZG	accessdata.fda.gov
April 8, 2026	K251666	SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant...	STERIS Corporation	Ohio	Substantially Equivalent	510(k) traditional	MED	accessdata.fda.gov
April 7, 2026	K260860	Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)	Basic Medical Technology, Inc.	California	Substantially Equivalent	510(k) traditional	LYZ	accessdata.fda.gov
April 2, 2026	K252137	BD Insyte IV Catheter	Becton Dickinson Infusion Therapy Systems, Inc.	Utah	Substantially Equivalent	510(k) traditional	FOZ	accessdata.fda.gov
April 2, 2026	K252130	LifeShield Infusion Safety Software Suite	Icu Medical, Inc.	Illinois	Substantially Equivalent	510(k) traditional	PHC	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Medtronic, Inc.	33	October 30, 2026
STERIS Corporation	9	June 24, 2026
CMT Health PTE., Ltd.	8	July 29, 2026
Epic Medical Pte. , Ltd.	8	June 12, 2026
Basic Medical Technology, Inc.	8	April 7, 2026
Icu Medical, Inc.	8	April 2, 2026
Promisemed Hangzhou Meditech Co., Ltd.	6	August 25, 2026
O&M Halyard, Inc.	6	July 21, 2026
Becton Dickinson Infusion Therapy Systems, Inc.	6	April 2, 2026
Steris	5	October 29, 2026
Hartalega NGC Sdn. Bhd.	5	July 20, 2026
Spectrum Vascular	4	August 10, 2026
Intera Oncology	4	March 16, 2026
Access Vascular, Inc.	4	August 1, 2025
Baxter Healthcare Corporation	4	July 28, 2025
B.Braun Medical, Inc.	3	October 22, 2026
Tsk Laboratory, Japan	3	October 6, 2026
Dentsply Sirona, Inc.	3	September 4, 2026
Cardinalhealth	3	September 2, 2026
Sol-Millennium Medical, Inc.	3	August 25, 2026

By decision type

Decision type	Decisions	Latest
510(k) traditional	258	October 30, 2026
510(k) special	67	October 29, 2026
PMA 30-day notice	25	October 30, 2026
510(k) abbreviated	8	September 11, 2026
PMA 180-day supplement	6	October 27, 2026
De Novo	6	August 19, 2026
PMA special supplement	4	August 29, 2025
PMA real-time process supplement	2	February 26, 2026
PMA 135-day supplement	2	January 20, 2026

By state or country

State or country	Decisions	Latest
China	41	October 30, 2026
California	39	October 16, 2026
Minnesota	37	October 30, 2026
Illinois	21	September 18, 2026
Ohio	17	October 29, 2026
Malaysia	17	October 1, 2026
Singapore	16	July 29, 2026
Massachusetts	15	August 31, 2026
Pennsylvania	12	October 22, 2026
Utah	12	April 2, 2026
New Jersey	10	July 13, 2026
Florida	9	September 2, 2026
New York	9	August 10, 2026
North Carolina	8	October 16, 2026
New Hampshire	7	July 24, 2026
Vietnam	6	October 29, 2026
Georgia	6	August 10, 2026
Switzerland	6	June 3, 2026
Japan	5	October 6, 2026
South Korea	5	May 21, 2026
Texas	4	September 25, 2026
Netherlands	4	August 19, 2026
Wisconsin	4	July 28, 2026
Virginia	4	April 20, 2026
Australia	4	April 17, 2026

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. 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.