Data / FDA device clearances / New Jersey

FDA device clearances in New Jersey: 165 since Nov 2024

Name: FDA device clearances for applicants in New Jersey
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA device clearances for applicants in New Jersey: 165 rows for $8.25, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 6 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 5 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.

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Updated October 29, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 165 device decisions for applicants in New Jersey from November 15, 2024 to October 29, 2026: 92 510(k) clearances and De Novo grants and 73 PMA approvals and supplements, for 52 applicants. The newest, K263628 on October 29, 2026, is ELEOS Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C) from Onkos Surgical, Inc..

The request: Every new FDA device clearance or approval for a company in New Jersey, with its address, the device and the product code. $10 of credit on sign-up, no card.

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165Decisions
92510(k) and De Novo
73PMA
October 29, 2026Latest decision

Newest decisions

The newest 100 of 165, 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 29, 2026	K263628	ELEOS Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C)	Onkos Surgical, Inc.	New Jersey	Substantially Equivalent	510(k) special	QZZ	accessdata.fda.gov
October 16, 2026	K252344	BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)	Becton, Dickinson and Company	New Jersey	Substantially Equivalent	510(k) traditional	JKA	accessdata.fda.gov
October 14, 2026	P180036/S046	OPTIMIZER Smart and Smart Mini System	Impulse Dynamics (Usa), Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	QFV	accessdata.fda.gov
September 24, 2026	P180036/S044	OPTIMIZER Smart System	Impulse Dynamics (Usa), Inc.	New Jersey	Approved	PMA real-time process supplement	QFV	accessdata.fda.gov
September 24, 2026	K260214	STA® - Liquid Anti-Xa	Diagnostica Stago, Inc.	New Jersey	Substantially Equivalent	510(k) special	KFF	accessdata.fda.gov
September 18, 2026	P900033/S117	INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft...	Integra Lifesciences Corp.	New Jersey	30-day notice accepted	PMA 30-day notice	MGR	accessdata.fda.gov
September 18, 2026	P850010/S119	Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent- Fibrillar...	Integra LifeSciences Corporation	New Jersey	30-day notice accepted	PMA 30-day notice	LMF	accessdata.fda.gov
September 18, 2026	P840062/S099	CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery	Integra Lifesciences Corp.	New Jersey	30-day notice accepted	PMA 30-day notice	LPG	accessdata.fda.gov
September 18, 2026	P810006/S115	Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent...	Integra LifeSciences Corporation	New Jersey	30-day notice accepted	PMA 30-day notice	LMF	accessdata.fda.gov
September 11, 2026	K261807	Sequential Circulator (SC-4004-DL, SC-4008-DL)	Bio Compression Systems, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	JOW	accessdata.fda.gov
September 8, 2026	K262341	b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem...	B-One Ortho, Corp.	New Jersey	Substantially Equivalent	510(k) traditional	JWH	accessdata.fda.gov
September 2, 2026	P010029/S043	EUFLEXXA® (1% sodium hyaluronate)	Ferring Pharmaceuticals, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	MOZ	accessdata.fda.gov
August 27, 2026	P240035/S004	ETHIZIA Hemostatic Patch	ETHICON, Inc.	New Jersey	Approved	PMA 180-day supplement	SGV	accessdata.fda.gov
August 21, 2026	K261466	Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM	Zeus Scientific	New Jersey	Substantially Equivalent	510(k) traditional	MOB	accessdata.fda.gov
August 6, 2026	K261898	Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System	Howmedica Osteonics Corp. dba Stryker Orthopaedics	New Jersey	Substantially Equivalent	510(k) traditional	KRO	accessdata.fda.gov
July 28, 2026	N12159/S129	SURGICELTM POWDER Absorbable Hemostatic Powder	ETHICON, Inc.	New Jersey	Approved	PMA 180-day supplement	LMG	accessdata.fda.gov
July 17, 2026	K262061	Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C...	Stryker Spine	New Jersey	Substantially Equivalent	510(k) special	ODP	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	K261624	Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert...	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	New Jersey	Substantially Equivalent	510(k) traditional	LPH	accessdata.fda.gov
July 7, 2026	K253942	Pulmonex II Xenon System (132-503)	Mirion Technologies (Capintec), Inc.	New Jersey	Substantially Equivalent	510(k) traditional	IYT	accessdata.fda.gov
June 26, 2026	K261039	i-STAT Crea cartridge with the i-STAT 1 System	Abbott Point of Care, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	CGL	accessdata.fda.gov
June 25, 2026	P880047/S070	GYNECARE INTERCEED Absorbable Adhesion Barrier	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	MCN	accessdata.fda.gov
June 25, 2026	P240035/S002	ETHIZIA Hemostatic Patch	ETHICON, Inc.	New Jersey	Approved	PMA panel track supplement	SGV	accessdata.fda.gov
June 25, 2026	N12159/S130	SURGICEL® Absorbable Hemostats	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	LMG	accessdata.fda.gov
June 25, 2026	K253394	Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture	ETHICON, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	GAM	accessdata.fda.gov
June 11, 2026	K253051	i-STAT hs-TnI cartridge with the i-STAT Alinity System	Abbott Point of Care, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	MMI	accessdata.fda.gov
June 8, 2026	K253066	ELEOS with NanoCept® Technology Limb Salvage System	Onkos Surgical, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	QZZ	accessdata.fda.gov
June 4, 2026	P850010/S118	Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent - Fibrillar...	Integra LifeSciences Corporation	New Jersey	30-day notice accepted	PMA 30-day notice	LMF	accessdata.fda.gov
June 4, 2026	P840062/S098	CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery	Integra Lifesciences Corp.	New Jersey	30-day notice accepted	PMA 30-day notice	LPG	accessdata.fda.gov
June 4, 2026	P810006/S114	Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent...	Integra LifeSciences Corporation	New Jersey	30-day notice accepted	PMA 30-day notice	LMF	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 27, 2026	P850010/S117	Helistat® Absorbable Collagen Hemostatic Agent	Integra LifeSciences Corporation	New Jersey	30-day notice accepted	PMA 30-day notice	LMF	accessdata.fda.gov
May 27, 2026	P840062/S097	CollaCote® and CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery	Integra Lifesciences Corp.	New Jersey	30-day notice accepted	PMA 30-day notice	LPG	accessdata.fda.gov
May 27, 2026	P810006/S113	Collastat Absorbable Collagen Hemostatic Sponge	Integra LifeSciences Corporation	New Jersey	30-day notice accepted	PMA 30-day notice	LMF	accessdata.fda.gov
May 18, 2026	K252047	STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices	ETHICON, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	NEW	accessdata.fda.gov
May 15, 2026	K253642	Jada System (Jada-2002)	Organon, LLC	New Jersey	Substantially Equivalent	510(k) traditional	OQY	accessdata.fda.gov
May 13, 2026	P180036/S043	OPTIMIZER Smart and Smart Mini	Impulse Dynamics (Usa), Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	QFV	accessdata.fda.gov
May 8, 2026	K250814	Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB	Zeus Scientific	New Jersey	Substantially Equivalent	510(k) traditional	OBE	accessdata.fda.gov
April 27, 2026	K253658	STA Satellite Max®	Diagnostica Stago, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	JPA	accessdata.fda.gov
April 27, 2026	K252445	Fusion Bioline Vascular Graft	Maquet Cardiovascular, LLC	New Jersey	Substantially Equivalent	510(k) traditional	DSY	accessdata.fda.gov
April 24, 2026	K261008	Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute...	Stryker Spine	New Jersey	Substantially Equivalent	510(k) special	MQV	accessdata.fda.gov
April 21, 2026	K250793	RhythmStar System (SL)	RhythMedix, LLC	New Jersey	Substantially Equivalent	510(k) traditional	QYX	accessdata.fda.gov
April 15, 2026	K260128	BD Preset and BD A-Line Arterial Blood Collection Syringes	Becton, Dickinson and Company	New Jersey	Substantially Equivalent	510(k) special	JKA	accessdata.fda.gov
April 13, 2026	K253357	b-ONE® Bipolar Head	B-One Ortho, Corp.	New Jersey	Substantially Equivalent	510(k) traditional	KWY	accessdata.fda.gov
April 10, 2026	P180036/S041	GUARDIO/VESTA Charger	Impulse Dynamics (Usa), Inc.	New Jersey	Approved	PMA real-time process supplement	QFV	accessdata.fda.gov
April 10, 2026	K252506	BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with...	Becton, Dickinson and Company	New Jersey	Substantially Equivalent	510(k) traditional	JKA	accessdata.fda.gov
April 10, 2026	K252378	BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube	Becton, Dickinson and Company	New Jersey	Substantially Equivalent	510(k) traditional	JKA	accessdata.fda.gov
March 27, 2026	K253572	STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA...	ETHICON, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	GAW	accessdata.fda.gov
March 20, 2026	K252005	Livi Device	Liviwell, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	HEB	accessdata.fda.gov
March 13, 2026	K252040	BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes	Becton, Dickinson and Company	New Jersey	Substantially Equivalent	510(k) traditional	JKA	accessdata.fda.gov
February 27, 2026	P080013/S030	DuraSeal Exact Spine Sealant System	Integra LifeSciences Corporation	New Jersey	Approved	PMA real-time process supplement	NQR	accessdata.fda.gov
February 27, 2026	P040034/S041	DuraSeal Dural Sealant System	Integra LifeSciences Corporation	New Jersey	Approved	PMA real-time process supplement	NQR	accessdata.fda.gov
February 26, 2026	P240035/S005	ETHIZIA Hemostatic Patch	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	SGV	accessdata.fda.gov
February 25, 2026	P900033/S116	INTEGRA ® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template; Integra® Omnigraft...	Integra Lifesciences Corp.	New Jersey	30-day notice accepted	PMA 30-day notice	MGR	accessdata.fda.gov
February 24, 2026	P240035/S006	ETHIZIA Hemostatic Patch	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	SGV	accessdata.fda.gov
February 20, 2026	K251653	SPRY TMS Therapy System (0550)	Soterix Medical, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	OBP	accessdata.fda.gov
February 19, 2026	K260205	AS Software Version Asera	AS Software, LLC	New Jersey	Substantially Equivalent	510(k) special	LLZ	accessdata.fda.gov
February 18, 2026	K253637	Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	New Jersey	Substantially Equivalent	510(k) traditional	MBH	accessdata.fda.gov
February 6, 2026	K253852	MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture	ETHICON, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	GAM	accessdata.fda.gov
January 28, 2026	P240035/S003	ETHIZIA Hemostatic Patch	ETHICON, Inc.	New Jersey	Approved	PMA 180-day supplement	SGV	accessdata.fda.gov
January 28, 2026	K252015	FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing	Koru Medical Systems, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	FRN	accessdata.fda.gov
January 22, 2026	P240035/S001	ETHIZIA Hemostatic Patch	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	SGV	accessdata.fda.gov
January 15, 2026	P880047/S069	GYNECARE INTERCEED Absorbable Adhesion Barrier	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	MCN	accessdata.fda.gov
January 15, 2026	N12159/S128	SURGICEL® Absorbable Hemostats	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	LMG	accessdata.fda.gov
January 15, 2026	K252283	Nano-Check Influenza A+B Test	Nano-Ditech Corporation	New Jersey	Substantially Equivalent	De Novo (dual track)	PSZ	accessdata.fda.gov
December 22, 2025	K252743	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue...	ETHICON, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	GAM	accessdata.fda.gov
December 19, 2025	K251011	Chiavaye Personal Moisturizer	Unipack, LLC	New Jersey	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
December 17, 2025	P080013/S029	DuraSeal Exact Spine Sealant System	Integra LifeSciences Corporation	New Jersey	30-day notice accepted	PMA 30-day notice	NQR	accessdata.fda.gov
December 17, 2025	P040034/S040	DuraSeal Dural Sealant System	Integra LifeSciences Corporation	New Jersey	30-day notice accepted	PMA 30-day notice	NQR	accessdata.fda.gov
December 16, 2025	K251256	PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family)...	Pentax of America, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	FDS	accessdata.fda.gov
December 15, 2025	P240035	ETHIZIA	ETHICON, Inc.	New Jersey	Approved	PMA original approval	SGV	accessdata.fda.gov
December 15, 2025	K252898	Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric...	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	New Jersey	Substantially Equivalent	510(k) traditional	KRO	accessdata.fda.gov
December 12, 2025	P880047/S068	INTERCEED Absorbable Adhesion Barrier	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	MCN	accessdata.fda.gov
December 12, 2025	N12159/S127	SURGICEL® Absorbable Hemostats	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	LMG	accessdata.fda.gov
December 12, 2025	K250974	Bio Arterial Deluxe (IC-BAP-DX)	Bio Compression Systems, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	JOW	accessdata.fda.gov
December 4, 2025	K250816	ADVIA Centaur Anti-Thyroglobulin II (aTgII)	Siemens Healthcare Diagnostics, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	JNL	accessdata.fda.gov
December 2, 2025	K250884	0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe	Becton, Dickinson and Company	New Jersey	Substantially Equivalent	510(k) traditional	NGT	accessdata.fda.gov
November 19, 2025	P180036/S034	OPTIMIZER SMART Mini IPG	Impulse Dynamics (Usa), Inc.	New Jersey	Approved	PMA 135-day supplement	QFV	accessdata.fda.gov
November 18, 2025	K251191	Collagen Dura Regeneration Membrane - Repair	Collagen Matrix, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	GXQ	accessdata.fda.gov
November 14, 2025	K251538	Status COVID-19/Flu A&B	Princeton BioMeditech Corp.	New Jersey	Substantially Equivalent	De Novo (dual track)	SCA	accessdata.fda.gov
November 12, 2025	K243897	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture	ETHICON, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	NEW	accessdata.fda.gov
November 4, 2025	N12159/S122	SURGICEL® Absorbable Hemostats	ETHICON, Inc.	New Jersey	Approved	PMA real-time process supplement	LMG	accessdata.fda.gov
October 24, 2025	K252044	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	New Jersey	Substantially Equivalent	510(k) traditional	MBH	accessdata.fda.gov
October 22, 2025	K253147	FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT...	Prosidyan, Inc.	New Jersey	Substantially Equivalent	510(k) special	MQV	accessdata.fda.gov
October 22, 2025	K250666	Alegria Flash CTD Screen	Zeus Scientific	New Jersey	Substantially Equivalent	510(k) traditional	LLL	accessdata.fda.gov
October 16, 2025	P010029/S042	EUFLEXXA® (1% SODIUM HYALURONATE)	Ferring Pharmaceuticals, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	MOZ	accessdata.fda.gov
October 15, 2025	K252920	ELEOS Limb Salvage System with NanoCept® Technology	Onkos Surgical, Inc.	New Jersey	Substantially Equivalent	510(k) special	QZZ	accessdata.fda.gov
October 15, 2025	K251294	Bonafix Implant Abutments	Zentek Medical, LLC	New Jersey	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
October 9, 2025	P880047/S067	GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED...	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	MCN	accessdata.fda.gov
October 9, 2025	N12159/S126	SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL...	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	LMG	accessdata.fda.gov
October 8, 2025	K251162	CUSA® Clarity Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	New Jersey	Substantially Equivalent	510(k) traditional	LFL	accessdata.fda.gov
October 8, 2025	K250536	MetaFore Small Screw System	Extremity Medical, LLC	New Jersey	Substantially Equivalent	510(k) traditional	HWC	accessdata.fda.gov
September 24, 2025	P880047/S066	GYNECARE INTERCEED Absorbable Adhesion Barrier	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	MCN	accessdata.fda.gov
September 24, 2025	N12159/S125	SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	LMG	accessdata.fda.gov
September 19, 2025	K250408	Alegria Flash ENA Screen	Zeus Scientific	New Jersey	Substantially Equivalent	510(k) traditional	LLL	accessdata.fda.gov
September 17, 2025	P000013/S027	Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System	Howmedica Osteonics Corp.	New Jersey	30-day notice accepted	PMA 30-day notice	MRA	accessdata.fda.gov
September 12, 2025	K250059	BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)	Becton, Dickinson and Company	New Jersey	Substantially Equivalent	510(k) traditional	ONB	accessdata.fda.gov
September 9, 2025	P900033/S115	INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft...	Integra Lifesciences Corp.	New Jersey	30-day notice accepted	PMA 30-day notice	MGR	accessdata.fda.gov
September 9, 2025	N12159/S123	SURGICEL BRAND ABSORBABLE HEMOSTAT	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	LMG	accessdata.fda.gov
September 4, 2025	P880047/S065	GYNECARE INTERCEED Absorbable Adhesion Barrier	ETHICON, Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	MCN	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
ETHICON, Inc.	37	August 27, 2026
Integra LifeSciences Corporation	15	September 18, 2026
Becton, Dickinson and Company	10	October 16, 2026
Impulse Dynamics (Usa), Inc.	10	October 14, 2026
Integra Lifesciences Corp.	10	September 18, 2026
Howmedica Osteonics Corp., Dba Stryker Orthopaedics	8	July 10, 2026
Zeus Scientific	5	August 21, 2026
Abbott Point of Care, Inc.	4	June 26, 2026
Pentax of America, Inc.	4	December 16, 2025
Onkos Surgical, Inc.	3	October 29, 2026
B-One Ortho, Corp.	3	September 8, 2026
Ferring Pharmaceuticals, Inc.	3	September 2, 2026
Maquet Cardiovascular, LLC	3	April 27, 2026
Extremity Medical, LLC	3	October 8, 2025
Diagnostica Stago, Inc.	2	September 24, 2026
Bio Compression Systems, Inc.	2	September 11, 2026
Stryker Spine	2	July 17, 2026
Nano-Ditech Corporation	2	January 15, 2026
Collagen Matrix, Inc.	2	November 18, 2025
Prosidyan, Inc.	2	October 22, 2025

By panel

Panel	Decisions	Latest
General, Plastic Surgery	46	September 18, 2026
Orthopedic	29	October 29, 2026
Cardiovascular	14	October 14, 2026
Obstetrics/Gynecology	13	June 25, 2026
Clinical Chemistry	11	October 16, 2026
General Hospital	10	July 13, 2026
Dental	8	September 18, 2026
Neurology	7	February 27, 2026
Immunology	6	August 21, 2026
Microbiology	5	January 15, 2026
Radiology	4	July 7, 2026
Gastroenterology, Urology	4	December 16, 2025
Unknown	3	October 8, 2025
Hematology	2	September 24, 2026
Ophthalmic	2	February 11, 2025
Pathology	1	June 20, 2025

By decision type

Decision type	Decisions	Latest
510(k) traditional	77	October 16, 2026
PMA 30-day notice	49	October 14, 2026
510(k) special	11	October 29, 2026
PMA real-time process supplement	9	September 24, 2026
PMA 180-day supplement	8	August 27, 2026
PMA 135-day supplement	4	November 19, 2025
De Novo (dual track)	3	January 15, 2026
PMA panel track supplement	1	June 25, 2026
PMA original approval	1	December 15, 2025
510(k) abbreviated	1	August 8, 2025
PMA special supplement	1	May 23, 2025

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.