Data / FDA device clearances / 510(k) traditional

FDA 510(k) traditional decisions: 5,367 since Nov 2024

Name: FDA 510(k) traditional decisions
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA 510(k) traditional decisions: 5,367 rows for $133.67, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 230 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 (contact, pathway, device name, applicant address, decision type, date received 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.

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

FDA made 5,367 device decisions of type 510(k) traditional from November 11, 2024 to October 30, 2026: 5,367 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 3,058 applicants. The newest, K263860 on October 30, 2026, is Shining3D Clear Aligner System from Hangzhou SHINING3D Dental Technology Co., Ltd..

The request: Every new FDA 510(k) traditional decision, with the applicant, its address, the device and the product code. $10 of credit on sign-up, no card.

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SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

5,367Decisions
5,367510(k) and De Novo
0PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 5,367, 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	K263860	Shining3D Clear Aligner System	Hangzhou SHINING3D Dental Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NXC	accessdata.fda.gov
October 30, 2026	K263232	eplex RP3 Control M530; eplex RP3 Negative	Maine Molecular Quality Controls, Inc.	Maine	Substantially Equivalent	510(k) traditional	PMN	accessdata.fda.gov
October 30, 2026	K263109	EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)	Ever Fortune.Ai, Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	QAS	accessdata.fda.gov
October 30, 2026	K263076	AngioVac F1885	AngioDynamics, Inc.	New York	Substantially Equivalent	510(k) traditional	DWF	accessdata.fda.gov
October 30, 2026	K263075	Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments	Strauss Surgical USA	Florida	Substantially Equivalent	510(k) traditional	FAJ	accessdata.fda.gov
October 30, 2026	K263063	B`orze Inc Laser Family (Sorren/Adonis)	Borze, Inc.	Idaho	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 30, 2026	K262971	Xpert® Hemorrhagic Fever Panel	Cepheid	California	Substantially Equivalent	510(k) traditional	QVR	accessdata.fda.gov
October 30, 2026	K262938	cobas eplex respiratory pathogen panel 3	GenMark Diagnostics, Inc.	California	Substantially Equivalent	510(k) traditional	QOF	accessdata.fda.gov
October 30, 2026	K262816	EXG PulseLinQ Cables (EXGPL)	Cb Innovations, LLC	California	Substantially Equivalent	510(k) traditional	DSA	accessdata.fda.gov
October 30, 2026	K262685	Zirconia Collective 4Y Dental Zirconia Blank	Zirconia Collective, Inc.	Colorado	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 30, 2026	K262470	Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)	Changsha Anxiang Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NGX	accessdata.fda.gov
October 30, 2026	K262066	Pleiades Device	My123Baby Medical Limited Dba Boost Fertility	Germany	Substantially Equivalent	510(k) traditional	MQK	accessdata.fda.gov
October 30, 2026	K261072	DS Core Detect	Dentsply Sirona, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	MYN	accessdata.fda.gov
October 30, 2026	K260648	PolySense	Itamar Medical , Ltd.	Israel	Substantially Equivalent	510(k) traditional	GWL	accessdata.fda.gov
October 30, 2026	K260575	AutoGel Pad (400-046,400-005)	Top-Rank Health Care Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MUI	accessdata.fda.gov
October 30, 2026	K260360	AesyBite Active	Aesyra SA	Switzerland	Substantially Equivalent	510(k) traditional	HCC	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 30, 2026	K260306	RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit...	Smith & Nephew Medical, Ltd.	United Kingdom	Substantially Equivalent	510(k) traditional	OMP	accessdata.fda.gov
October 30, 2026	K260058	Kerecis Express (50250)	Kerecis Limited	Iceland	Substantially Equivalent	510(k) traditional	KGN	accessdata.fda.gov
October 30, 2026	K253095	ULSPIRA TS Nitric Oxide Therapy System	Airgas Therapeutics, LLC	Pennsylvania	Substantially Equivalent	510(k) traditional	MRN	accessdata.fda.gov
October 29, 2026	K263459	SWICS	Bloom Surgical, Inc.	Utah	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
October 29, 2026	K263065	MicroPort Total Knee System	Suzhou Microport Orthorecon Co., Ltd.	China	Substantially Equivalent	510(k) traditional	JWH	accessdata.fda.gov
October 29, 2026	K262960	Cerclage Cabling System	Pioneer Surgical Technology, Inc. dba EXALTA Group	Michigan	Substantially Equivalent	510(k) traditional	JDQ	accessdata.fda.gov
October 29, 2026	K262756	Zirconia Dental Ceramics and Staining Solution	Fanen New Materials Technology (Suzhou) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 29, 2026	K262731	Virata Spinal Fixation System	SeaSpine Orthopedics Corporation	California	Substantially Equivalent	510(k) traditional	NKB	accessdata.fda.gov
October 29, 2026	K262574	Convoy Expandable Corpectomy System	SeaSpine Orthopedics Corporation	California	Substantially Equivalent	510(k) traditional	MQP	accessdata.fda.gov
October 29, 2026	K262572	Symmetrix PX Spinal System	Medtronic Sofamor Danek USA, Inc.	Tennessee	Substantially Equivalent	510(k) traditional	MAX	accessdata.fda.gov
October 29, 2026	K262570	TZ Medical Birthing Balloon Kit	TZ Medical	Oregon	Substantially Equivalent	510(k) traditional	PFJ	accessdata.fda.gov
October 29, 2026	K262437	Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)	Zhejiang Geyi Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
October 29, 2026	K262415	OSSIX Plus	Datum Dental, Ltd.	Israel	Substantially Equivalent	510(k) traditional	NPL	accessdata.fda.gov
October 29, 2026	K262318	Minder® System	Epi-Minder Pty, Ltd.	Australia	Substantially Equivalent	510(k) traditional	SEM	accessdata.fda.gov
October 29, 2026	K262125	Nenesupply Venus Handsfree Breast Pump (NBP001-HF)	Nenesupply Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
October 29, 2026	K260975	Libertas Acetabular Liners (Acetabular Liner)	Maxx Orthopedics, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	JDI	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	K260356	EndoColibri	Koehrer Medical Engineering GmbH	Germany	Substantially Equivalent	510(k) traditional	NYL	accessdata.fda.gov
October 29, 2026	K260337	SEEG-Tx® System (STX-SYS-001)	Dixi Medical	France	Substantially Equivalent	510(k) traditional	GXD	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	K263313	Red Light Therapy Hair Growth Cap (RB-009, RB-011, RB-012, RB-088, RB-089, RB-092)	Shenzhen Rainbow Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OAP	accessdata.fda.gov
October 28, 2026	K263005	Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)	Anhui Longway Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 28, 2026	K262343	Dynavisc	Fziomed, Inc.	California	Substantially Equivalent	510(k) traditional	OWW	accessdata.fda.gov
October 28, 2026	K262242	Profoject Safe Push Button Blood Collection Sets	CMT Health PTE., Ltd.	Singapore	Substantially Equivalent	510(k) traditional	JKA	accessdata.fda.gov
October 28, 2026	K261676	uPMR Zenith	Shanghai United Imaging Healthcare Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OUO	accessdata.fda.gov
October 28, 2026	K261648	Evident Vascular Guidance System	Evident Vascular, Inc.	California	Substantially Equivalent	510(k) traditional	IYO	accessdata.fda.gov
October 28, 2026	K261636	Microwave Ablation Antennas	Canyon Medical, Inc.	China	Substantially Equivalent	510(k) traditional	NEY	accessdata.fda.gov
October 28, 2026	K261630	GI Windows Flexagon Plus OTOLoc System	GI Windows Surgical	Massachusetts	Substantially Equivalent	510(k) traditional	SAH	accessdata.fda.gov
October 28, 2026	K261628	LymphaTech Mobile 3D Measuring Tool	Lymphatech, Inc.	Georgia	Substantially Equivalent	510(k) traditional	OBH	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 28, 2026	K260670	YUWELL® Electronic Blood Pressure Monitor	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	China	Substantially Equivalent	510(k) traditional	DXN	accessdata.fda.gov
October 28, 2026	K260311	Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview 60 UV toric (Omafilcon...	St. shine Optical Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
October 28, 2026	K260310	HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown...	O&M Halyard, Inc.	Georgia	Substantially Equivalent	510(k) traditional	QSO	accessdata.fda.gov
October 27, 2026	K262775	AquaVance Clear Fluoride Treatment	The Belport Company Inc., DBA Gingi-Pak	California	Substantially Equivalent	510(k) traditional	LBH	accessdata.fda.gov
October 27, 2026	K262531	OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy...	Teleflex Medical, LLC	North Carolina	Substantially Equivalent	510(k) traditional	KNW	accessdata.fda.gov
October 27, 2026	K262349	Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)	Risu Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 27, 2026	K262229	DORO® Headrest System for AVA	Black Forest Medical GmbH	Germany	Substantially Equivalent	510(k) traditional	HBL	accessdata.fda.gov
October 27, 2026	K261740	Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)	Robotrak Technologies Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MYC	accessdata.fda.gov
October 27, 2026	K261714	FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors	Transonic Systems, Inc.	New York	Substantially Equivalent	510(k) traditional	DPW	accessdata.fda.gov
October 27, 2026	K261512	OsteoSight Spine (v1)	Naitive Technologies, Ltd.	United Kingdom	Substantially Equivalent	510(k) traditional	SAO	accessdata.fda.gov
October 27, 2026	K260586	Nimbl Pneumatic Compression System	Tactile Medical	Minnesota	Substantially Equivalent	510(k) traditional	JOW	accessdata.fda.gov
October 27, 2026	K260520	Skin Clinic Nitro Clear for Warts and Skin Tags	Cryoconcepts LP	Pennsylvania	Substantially Equivalent	510(k) traditional	GEH	accessdata.fda.gov
October 27, 2026	K254226	PulseAPI SmartWatch	PulseAI, Ltd.	United Kingdom	Substantially Equivalent	510(k) traditional	DQK	accessdata.fda.gov
October 26, 2026	K262984	Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06...	Shenzhen Bway Tech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OHS	accessdata.fda.gov
October 26, 2026	K262864	FLOWRUNNER Aspiration System	Expanse Medical, Inc.	California	Substantially Equivalent	510(k) traditional	QEZ	accessdata.fda.gov
October 26, 2026	K262720	SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max)	Single Pass, Inc.	California	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
October 26, 2026	K262627	Fractional CO2 Laser Therapy System (Z121)	Sanhe PERFECTLASER Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 26, 2026	K262567	GPS Ankle	Blue Ortho	France	Substantially Equivalent	510(k) traditional	OLO	accessdata.fda.gov
October 26, 2026	K262280	Mouth guard	Dongguan Yiyao Science & Technology Development Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OBR	accessdata.fda.gov
October 26, 2026	K262276	Cyperus	Contrario Medical, Inc.	Texas	Substantially Equivalent	510(k) traditional	MQK	accessdata.fda.gov
October 26, 2026	K261997	NeuroAlign	Medivis, Inc.	New York	Substantially Equivalent	510(k) traditional	HAW	accessdata.fda.gov
October 26, 2026	K261763	MIM KineticID	Mim Software, Inc.	Ohio	Substantially Equivalent	510(k) traditional	LLZ	accessdata.fda.gov
October 26, 2026	K261625	FAQ (FAQ 401);FAQ (FAQ 402)	Foreo, Inc.	Nevada	Substantially Equivalent	510(k) traditional	NFO	accessdata.fda.gov
October 26, 2026	K261156	Power Wheelchair (DC07, DC07M, DC08M, DC09F, DC10M)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 26, 2026	K261155	Power Wheelchair (DC07A, DC07S, DC08A, DC08S, DC09, DC09A, DC09S, DC09M, DC10A, DC10S)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 26, 2026	K261135	Trochlear Salvage Plating System	Skeletal Dynamics, Inc.	Florida	Substantially Equivalent	510(k) traditional	HRS	accessdata.fda.gov
October 26, 2026	K260671	RP Check (RP01)	MD Diagnostics, Ltd.	United Kingdom	Substantially Equivalent	510(k) traditional	CAP	accessdata.fda.gov
October 26, 2026	K260350	Cysto-Urethroscopes and accessories	Hangzhou Hawk Optical Electronic Instruments Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FJL	accessdata.fda.gov
October 26, 2026	K260285	Triad Hydrophilic Wound Dresssing (1964, 2.5 oz); Triad Hydrophilic Wound Dressing (1967, 6 oz)	Coloplast Corp.	Minnesota	Substantially Equivalent	510(k) traditional	FRO	accessdata.fda.gov
October 23, 2026	K262779	ANTHEM Fracture System	Globus Medical, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	HRS	accessdata.fda.gov
October 23, 2026	K262752	Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)	Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OHS	accessdata.fda.gov
October 23, 2026	K262080	OTOPLAN	Cascination AG	Switzerland	Substantially Equivalent	510(k) traditional	QQE	accessdata.fda.gov
October 23, 2026	K261982	RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)	Smith & Nephew Medical, Ltd.	United Kingdom	Substantially Equivalent	510(k) traditional	OMP	accessdata.fda.gov
October 23, 2026	K261792	DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent	Medtronic	Minnesota	Substantially Equivalent	510(k) traditional		accessdata.fda.gov
October 23, 2026	K261679	BlineSlide	Deep Breathe, Inc.	Canada	Substantially Equivalent	510(k) traditional	POK	accessdata.fda.gov
October 23, 2026	K261670	Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation...	Poly Medicure Limited	India	Substantially Equivalent	510(k) traditional	LJH	accessdata.fda.gov
October 23, 2026	K260776	VENTANA MMR IHC Panel	Roche Tissue Diagnostics, Inc.	Arizona	Substantially Equivalent	510(k) traditional	PZJ	accessdata.fda.gov
October 23, 2026	K260640	Kinetic Software Library	Monebo Technologies, Inc.	Texas	Substantially Equivalent	510(k) traditional	DPS	accessdata.fda.gov
October 23, 2026	K260421	LuxDesign	LuxCreo, Inc.	Illinois	Substantially Equivalent	510(k) traditional	PNN	accessdata.fda.gov
October 23, 2026	K260302	B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC	B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)	Germany	Substantially Equivalent	510(k) traditional	SJQ	accessdata.fda.gov
October 23, 2026	K260275	Mobile Dental Solution (Model: DS50, DS70, DS90)	Guangdong JINME Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EIA	accessdata.fda.gov
October 23, 2026	K260251	BreathCare PAP III (YH-390N)	Suzhou Yuyue Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	BZD	accessdata.fda.gov
October 23, 2026	K253875	OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric...	Visco Vision, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
October 22, 2026	K262701	PicoPeak Picosecond Nd:Yag Laser System (Bella-9)	Beijing Sea Heart International Science and Technologyco.Ltd	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 22, 2026	K262184	GANNET®	BAAT Medical Products B.V.	Netherlands	Substantially Equivalent	510(k) traditional	JDO	accessdata.fda.gov
October 22, 2026	K262126	Cerclage Wires;K-wires;Steinmann Pins	MK Medical GmbH	Germany	Substantially Equivalent	510(k) traditional	HTY	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	K261565	FAQ (FAQ 411)	Foreo, Inc.	Nevada	Substantially Equivalent	510(k) traditional	NFO	accessdata.fda.gov
October 22, 2026	K261295	MultiNeO Dental Implant System	Alpha Bio Tec , Ltd.	Israel	Substantially Equivalent	510(k) traditional	DZE	accessdata.fda.gov
October 22, 2026	K260920	Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc...	Berkeley Advanced Biomaterials	California	Substantially Equivalent	510(k) traditional	KGN	accessdata.fda.gov
October 22, 2026	K260686	Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter	Zylox Medtech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PNO	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 22, 2026	K260230	Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)	Suzhou Medical Appliance Factory	China	Substantially Equivalent	510(k) traditional	BWK	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Intuitive Surgical, Inc.	32	October 14, 2026
Arthrex, Inc.	28	September 24, 2026
Olympus Medical Systems Corporation	28	August 27, 2026
Shanghai United Imaging Healthcare Co., Ltd.	24	October 28, 2026
Siemens Medical Solutions USA, Inc.	24	September 25, 2026
Medacta International S.A.	22	September 17, 2026
Karl Storz SE & CO. KG	19	October 14, 2026
Fujifilm Corporation	19	October 9, 2026
Shenzhen Kaiyan Medical Equipment Co., Ltd.	19	July 23, 2026
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	18	October 16, 2026
GE Medical Systems Ultrasound and Primary Care Diagnostics	18	September 16, 2026
Beckman Coulter, Inc.	16	October 20, 2026
Olympus Medical Systems Corp.	16	September 10, 2026
Dentsply Sirona, Inc.	15	October 30, 2026
Fresenius Medical Care Renal Therapies Group, LLC	15	October 19, 2026
Roche Diagnostics	15	October 2, 2026
Varian Medical Systems, Inc.	15	August 3, 2026
Canon Medical Systems Corporation	15	May 20, 2026
Philips Ultrasound, LLC	14	September 25, 2026
Shenzhen TPH Technology Co., Ltd.	14	September 17, 2026

By panel

Panel	Decisions	Latest
Radiology	836	October 30, 2026
Orthopedic	643	October 29, 2026
General, Plastic Surgery	619	October 30, 2026
Cardiovascular	564	October 30, 2026
Gastroenterology, Urology	436	October 30, 2026
Dental	401	October 30, 2026
Neurology	341	October 30, 2026
General Hospital	258	October 30, 2026
Physical Medicine	233	October 30, 2026
Anesthesiology	191	October 30, 2026
Obstetrics/Gynecology	173	October 30, 2026
Microbiology	160	October 30, 2026
Unknown	138	October 30, 2026
Clinical Chemistry	101	October 28, 2026
Ear, Nose, Throat	81	October 14, 2026
Ophthalmic	72	October 28, 2026
Immunology	40	October 30, 2026
Clinical Toxicology	32	September 10, 2026
Hematology	24	October 20, 2026
Pathology	23	October 15, 2026
Medical Genetics	1	July 2, 2026

By state or country

State or country	Decisions	Latest
China	1,027	October 30, 2026
California	667	October 30, 2026
South Korea	284	October 21, 2026
Germany	199	October 30, 2026
Massachusetts	176	October 28, 2026
Florida	161	October 30, 2026
Pennsylvania	140	October 30, 2026
Japan	136	October 16, 2026
Israel	124	October 30, 2026
France	121	October 29, 2026
Texas	114	October 26, 2026
Taiwan	108	October 30, 2026
Switzerland	108	October 30, 2026
Illinois	108	October 23, 2026
Minnesota	105	October 27, 2026
United Kingdom	92	October 30, 2026
Canada	87	October 23, 2026
New York	84	October 30, 2026
Italy	78	October 2, 2026
New Jersey	77	October 16, 2026
Indiana	65	October 2, 2026
Colorado	64	October 30, 2026
Ohio	59	October 28, 2026
Netherlands	57	October 22, 2026
Utah	54	October 29, 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.