Data / FDA device clearances / Ear, Nose, Throat

FDA Ear, Nose, Throat device clearances: 147 since Nov 2024

Name: FDA ear, nose, throat device clearances and approvals
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA ear, nose, throat device clearances and approvals: 147 rows for $7.35, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 10 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, 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/ear-nose-throat, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 15, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 147 device decisions in ear, nose, throat (FDA review panel) from November 13, 2024 to October 15, 2026: 93 510(k) clearances and De Novo grants and 54 PMA approvals and supplements, for 73 applicants. The newest, P090018/S044 on October 15, 2026, is Esteem® from Envoy Medical Corporation.

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

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147Decisions
93510(k) and De Novo
54PMA
October 15, 2026Latest decision

Newest decisions

The newest 100 of 147, 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 15, 2026	P090018/S044	Esteem®	Envoy Medical Corporation	Minnesota	30-day notice accepted	PMA 30-day notice	OAF	accessdata.fda.gov
October 14, 2026	K260264	Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)	Shanghai Medi Astro Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ETA	accessdata.fda.gov
October 9, 2026	P000025/S136	MED-EL Cochlear Implant System	Med-El Corp.		Approved	PMA 135-day supplement	MCM	accessdata.fda.gov
September 28, 2026	P970051/S244	Nucleus® 24 Cochlear Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
September 28, 2026	P890027/S067	Nucleus® 22 Cochlear Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
September 28, 2026	P840024/S099	Nucleus® 22 Cochlear Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
September 28, 2026	P130016/S061	Cochlear Hybrid Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	PGQ	accessdata.fda.gov
September 28, 2026	P000015/S057	Cochlear Auditory Brainstem Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MHE	accessdata.fda.gov
September 23, 2026	P100044/S060	Propel Family Products	Intersect Ent.	California	Approved	PMA real-time process supplement	OWO	accessdata.fda.gov
September 23, 2026	K261637	Single-use Flexible Bronchoscope	Hunan Vathin Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
September 22, 2026	P100044/S061	PROPEL	Intersect Ent.	California	30-day notice accepted	PMA 30-day notice	OWO	accessdata.fda.gov
September 21, 2026	K261725	OtoCompanion (Version 1.0)	Ironsides Medical, Inc.	Massachusetts	Substantially Equivalent	510(k) traditional	SHL	accessdata.fda.gov
September 18, 2026	P960058/S178	CLARION MULTI-STRATEGY COCHLEAR IMPLANT	Advanced Bionics	California	Approved	PMA 180-day supplement	MCM	accessdata.fda.gov
September 16, 2026	K260309	Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set	Ambu A/S	Denmark	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
September 15, 2026	K254299	CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation...	Karl Storz SE & CO. KG	Germany	Substantially Equivalent	510(k) traditional	EOB	accessdata.fda.gov
September 4, 2026	P960058/S177	HiResolution Bionic Ear System	Advanced Bionics	California	Approved	PMA special supplement	MCM	accessdata.fda.gov
September 2, 2026	K254026	3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U)...	Flexicare Medical Limited.	United Kingdom	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
August 26, 2026	K261142	Ponto 5 Mini; Ponto 5 Superpower	Oticon Medical AB	Sweden	Substantially Equivalent	510(k) special	MAH	accessdata.fda.gov
August 19, 2026	K253431	Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR...	Shokz Health Global Limited	Hong Kong	Substantially Equivalent	510(k) traditional	LXB	accessdata.fda.gov
August 18, 2026	K260266	Tympendi (810)	Grace Medical, Inc.	Tennessee	Substantially Equivalent	510(k) traditional	KHJ	accessdata.fda.gov
August 13, 2026	K260413	Levo Gen 2 Tinnitus Therapy System	Levo Medical Corporation	Canada	Substantially Equivalent	510(k) traditional	KLW	accessdata.fda.gov
July 31, 2026	P190016/S012	Tula® System	Tusker Medical, Inc.	California	30-day notice accepted	PMA 30-day notice	QJA	accessdata.fda.gov
July 31, 2026	P100044/S059	Propel, Propel Mini (including Propel Mini with Straight Delivery System), and Propel Contour Sinus Implants	Intersect Ent.	California	Approved	PMA 135-day supplement	OWO	accessdata.fda.gov
July 31, 2026	K261187	Hearing Aid Feature	Samsung Electronics Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	SCR	accessdata.fda.gov
July 30, 2026	K260620	SeptAlign (SPLN001)	Spirair, Inc.	Ca	Substantially Equivalent	510(k) traditional	NHB	accessdata.fda.gov
July 25, 2026	K260382	MONARCH Platform (MON-000008)	Auris Health, Inc.	California	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
July 24, 2026	K261274	EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial...	Cook Ireland, Ltd.	Ireland	Substantially Equivalent	510(k) traditional	KTI	accessdata.fda.gov
July 22, 2026	P960058/S167	HiResolution Bionic Ear System	Advanced Bionics	California	Approved	PMA panel track supplement	MCM	accessdata.fda.gov
July 22, 2026	K254296	Ossiclear (Ossiclear System)	Sounduct	France	Substantially Equivalent	510(k) traditional	LXB	accessdata.fda.gov
July 13, 2026	K254044	Hearing assist	Meta Platform Technologies, LLC	California	Substantially Equivalent	510(k) traditional	SCR	accessdata.fda.gov
July 10, 2026	K260902	Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear...	Cochlear Americas	Colorado	Substantially Equivalent	510(k) traditional	PFO	accessdata.fda.gov
July 10, 2026	K254037	LungFlow Airway Catheter	Free Flow Medical, Inc.	California	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
June 25, 2026	K260992	iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)	Neuralytix	Colorado	Substantially Equivalent	510(k) traditional	PDQ	accessdata.fda.gov
June 25, 2026	K254108	Jabra Enhance Select Self-fit (Jabra Enhance Select 550)	GN Hearing A/S	Denmark	Substantially Equivalent	510(k) traditional	QUH	accessdata.fda.gov
June 17, 2026	K261544	Hydro Irrigation System	Stryker Instruments	Michigan	Substantially Equivalent	510(k) traditional	EOB	accessdata.fda.gov
June 16, 2026	K253137	FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T	Fujifilm Corporation	Japan	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
June 15, 2026	K260452	Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156...	Zdeer Technology (Henan) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	LXB	accessdata.fda.gov
June 11, 2026	K261256	Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)	Shenzhen Magnet Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	LXB	accessdata.fda.gov
June 10, 2026	K260614	Tinnitus Therapy	Sivantos GmbH	Germany	Substantially Equivalent	510(k) special	KLW	accessdata.fda.gov
June 3, 2026	P090018/S043	Esteem®	Envoy Medical Corporation	Minnesota	30-day notice accepted	PMA 30-day notice	OAF	accessdata.fda.gov
May 21, 2026	P090018/S042	Esteem®	Envoy Medical Corporation	Minnesota	Approved	PMA real-time process supplement	OAF	accessdata.fda.gov
May 15, 2026	K252624	KARL STORZ Laryngoscopes and Accessories	KARL STORZ Endoscopy-America, Inc.	California	Substantially Equivalent	510(k) traditional	EQN	accessdata.fda.gov
May 14, 2026	K260565	SmartClip Delivery Catheter (ADR-1715)	Elucent Medical	Minnesota	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
May 14, 2026	K254133	ENTity USB Videoscope System	Optim, LLC	Massachusetts	Substantially Equivalent	510(k) traditional	EOB	accessdata.fda.gov
April 30, 2026	P970051/S242	Nucleus® 24 Cochlear Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
April 30, 2026	P130016/S060	Cochlear Hybrid Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	PGQ	accessdata.fda.gov
April 30, 2026	P000015/S056	Cochlear Auditory Brainstem Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MHE	accessdata.fda.gov
April 26, 2026	K253580	Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)	Tedan Surgical Innovations	Texas	Substantially Equivalent	510(k) traditional	PDQ	accessdata.fda.gov
April 23, 2026	K252436	Tula Tympanostomy Tube Delivery Device	Tusker Medical, Inc.	Texas	Substantially Equivalent	510(k) traditional	ETD	accessdata.fda.gov
April 23, 2026	K252341	EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS...	Olympus Medical Systems Corp.	Japan	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
April 16, 2026	P960058/S175	HiResolution Bionic Ear System	Advanced Bionics	California	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
April 16, 2026	P960058/S173	HiResolution Bionic Ear System	Advanced Bionics	California	Approved	PMA 135-day supplement	MCM	accessdata.fda.gov
April 16, 2026	K251478	ClearTip TBNA Type	Finemedix Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	KTI	accessdata.fda.gov
April 9, 2026	P960058/S174	HiResolution Bionic Ear System Ultra and Ultra 3D Thin PCB	Advanced Bionics	California	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
April 8, 2026	K260420	LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)	MacroLux Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
April 3, 2026	K260720	mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING...	MED-EL Elektromedizinische Geräte GmbH	Austria	Substantially Equivalent	510(k) special	ETB	accessdata.fda.gov
April 3, 2026	K260719	mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis...	MED-EL Elektromedizinische Geräte GmbH	Austria	Substantially Equivalent	510(k) special	ETA	accessdata.fda.gov
April 3, 2026	K260718	mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial...	MED-EL Elektromedizinische Geräte GmbH	Austria	Substantially Equivalent	510(k) special	ETB	accessdata.fda.gov
March 25, 2026	K253184	Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)	Zhuhai Wesee Meditech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EOB	accessdata.fda.gov
March 20, 2026	K252050	Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D	Olympus Medical Systems Corporation	Japan	Substantially Equivalent	510(k) traditional	EOB	accessdata.fda.gov
March 17, 2026	DEN250014	Tyto Insights for Eardrum Bulging Detection	Tyto Care , Ltd.	Israel	Unknown	De Novo	SHL	accessdata.fda.gov
March 12, 2026	K254040	LungFlow Basket Catheter	Free Flow Medical, Inc.	California	Substantially Equivalent	510(k) traditional	KTI	accessdata.fda.gov
March 4, 2026	DEN250012	LifeVac	Lifevac, LLC	New York	Unknown	De Novo	QXN	accessdata.fda.gov
March 2, 2026	K260003	KARL STORZ Mediastinoscopes and Instruments	Karl Storz SE & CO. KG	Germany	Substantially Equivalent	510(k) traditional	EWY	accessdata.fda.gov
February 27, 2026	K253536	Evala Nerve Stimulator (EPNR002)	Epineuron Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	ETN	accessdata.fda.gov
February 19, 2026	K253612	Acclarent AERA Eustachian Tube Balloon Dilation System	Acclarent, Inc.	California	Substantially Equivalent	510(k) traditional	PNZ	accessdata.fda.gov
February 10, 2026	K251672	NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence...	Medtronic Xomed, Inc.	Florida	Substantially Equivalent	510(k) traditional	ETN	accessdata.fda.gov
January 23, 2026	P960058/S170	HiResolution Bionic Ear System	Advanced Bionics	California	Approved	PMA 135-day supplement	MCM	accessdata.fda.gov
January 23, 2026	P000025/S137	MED-EL Cochlear Implant	Med-El Corp.		Approved	PMA 180-day supplement	MCM	accessdata.fda.gov
January 21, 2026	P190016/S011	Tula Tube Delivery System (TDS)	Tusker Medical, Inc.	California	30-day notice accepted	PMA 30-day notice	QJA	accessdata.fda.gov
January 16, 2026	K251790	SeptAlign	Spirair, Inc.	Ca	Substantially Equivalent	510(k) traditional	NHB	accessdata.fda.gov
January 9, 2026	K252339	iotaSOFT® Insertion System	Iotamotion, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	QQH	accessdata.fda.gov
December 19, 2025	P970051/S240	NUCLEUS 24 COCHLEAR IMPLANT SYSTEM	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
December 19, 2025	K251402	LIA-1 Catheter (542-1)	Leadoptik, Inc.	California	Substantially Equivalent	510(k) traditional	KTI	accessdata.fda.gov
December 12, 2025	K250863	FUJIFILM Ultrasonic Endoscope EB-710US	Fujifilm Corporation	Japan	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
December 5, 2025	K251731	KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)	Karl Storz SE & CO. KG	Germany	Substantially Equivalent	510(k) special	EOQ	accessdata.fda.gov
November 26, 2025	P000025/S134	MED-EL CI System	Med-El Corp.		Approved	PMA panel track supplement	MCM	accessdata.fda.gov
November 7, 2025	P100044/S058	Propel Contour Sinus Implant	Intersect Ent.	California	Approved	PMA real-time process supplement	OWO	accessdata.fda.gov
October 24, 2025	P190016/S010	Tula® System	Tusker Medical, Inc.	California	30-day notice accepted	PMA 30-day notice	QJA	accessdata.fda.gov
October 16, 2025	P970051/S236	Nucleus® 24 Cochlear Implant System	Cochlear Americas	Colorado	Approved	PMA real-time process supplement	MCM	accessdata.fda.gov
October 16, 2025	P130016/S058	Nucleus® Hybrid L24 Cochlear Implant System	Cochlear Americas	Colorado	Approved	PMA real-time process supplement	PGQ	accessdata.fda.gov
October 14, 2025	P960058/S172	HiResolution Bionic Ear System	Advanced Bionics	California	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
October 8, 2025	K252874	Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01	Serpex Medical, Inc.	California	Substantially Equivalent	510(k) special	KTI	accessdata.fda.gov
September 26, 2025	P970051/S238	Nucleus® 24 Cochlear Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
September 26, 2025	K252921	Radial Jaw 4 Pulmonary Biopsy Forceps	Boston Scientific Corporation	Massachusetts	Substantially Equivalent	510(k) special	BWH	accessdata.fda.gov
September 26, 2025	K251208	Tuned Self-Fitting Mobile App	Tuned , Ltd.	Israel	Substantially Equivalent	510(k) traditional	SCR	accessdata.fda.gov
September 23, 2025	K252045	Ion Endoluminal System (IF1000)	Intuitive Surgical, Inc.	California	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
September 23, 2025	K251894	Himaging Bronchscope System	Himaging Technology (Shanghai) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
September 5, 2025	K252528	Ion Endoluminal System (IF1000)	Intuitive Surgical, Inc.	California	Substantially Equivalent	510(k) special	EOQ	accessdata.fda.gov
September 2, 2025	P970051/S237	Cochlear Nucleus® System	Cochlear Americas	Colorado	Approved	PMA 180-day supplement	MCM	accessdata.fda.gov
August 29, 2025	K250874	Sunrise	Sunrise SA	Belgium	Substantially Equivalent	510(k) traditional	QRS	accessdata.fda.gov
August 27, 2025	K251752	Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)	Shanghai AnQing Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
August 20, 2025	P960058/S171	HiResolution Bionic Ear System	Advanced Bionics	California	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
August 11, 2025	K251823	UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO...	Zhejiang UE Medical Corp.	China	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
August 11, 2025	K241731	Outlook Surgical Versa One System (8900139)	Resnent, LLC	Illinois	Substantially Equivalent	510(k) traditional	EOB	accessdata.fda.gov
August 6, 2025	P970051/S235	Nucleus® 24 Cochlear Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
July 29, 2025	K251664	Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)	Olympus Medical Systems Corporation	Japan	Substantially Equivalent	510(k) traditional	KTI	accessdata.fda.gov
July 25, 2025	K250232	Vathin® Video Bronchoscope System	Hunan Vathin Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
July 24, 2025	P970051/S234	Nucleus® 24 Cochlear Implant System	Cochlear Americas	Colorado	30-day notice accepted	PMA 30-day notice	MCM	accessdata.fda.gov
July 11, 2025	K243655	TurbAlign	Spirair, Inc.	Ca	Substantially Equivalent	510(k) traditional	LYA	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Cochlear Americas	24	September 28, 2026
Advanced Bionics	12	September 18, 2026
Intersect Ent.	7	September 23, 2026
MED-EL Elektromedizinische Geräte GmbH	6	April 3, 2026
Olympus Medical Systems Corporation	6	March 20, 2026
Med-El Corp.	5	October 9, 2026
Tusker Medical, Inc.	5	July 31, 2026
Envoy Medical Corporation	3	October 15, 2026
Hunan Vathin Medical Instrument Co., Ltd.	3	September 23, 2026
Karl Storz SE & CO. KG	3	September 15, 2026
Spirair, Inc.	3	July 30, 2026
Fujifilm Corporation	3	June 16, 2026
Olympus Medical Systems Corp.	3	April 23, 2026
Auris Health, Inc.	2	July 25, 2026
Free Flow Medical, Inc.	2	July 10, 2026
Intuitive Surgical, Inc.	2	September 23, 2025
Shanghai AnQing Medical Instrument Co., Ltd.	2	August 27, 2025
Shanghai Medi Astro Technology Co., Ltd.	1	October 14, 2026
Ironsides Medical, Inc.	1	September 21, 2026
Ambu A/S	1	September 16, 2026

By decision type

Decision type	Decisions	Latest
510(k) traditional	81	October 14, 2026
PMA 30-day notice	31	October 15, 2026
PMA 180-day supplement	11	September 18, 2026
510(k) special	10	August 26, 2026
PMA real-time process supplement	5	September 23, 2026
PMA 135-day supplement	4	October 9, 2026
PMA panel track supplement	2	July 22, 2026
De Novo	2	March 17, 2026
PMA special supplement	1	September 4, 2026

By state or country

State or country	Decisions	Latest
California	36	September 23, 2026
Colorado	27	September 28, 2026
China	16	October 14, 2026
Japan	12	June 16, 2026
Austria	8	April 3, 2026
Minnesota	5	October 15, 2026
Germany	5	September 15, 2026
Massachusetts	3	September 21, 2026
Ca	3	July 30, 2026
Denmark	2	September 16, 2026
Canada	2	August 13, 2026
South Korea	2	July 31, 2026
Ireland	2	July 24, 2026
France	2	July 22, 2026
Texas	2	April 26, 2026
Israel	2	March 17, 2026
United Kingdom	1	September 2, 2026
Sweden	1	August 26, 2026
Hong Kong	1	August 19, 2026
Tennessee	1	August 18, 2026
Michigan	1	June 17, 2026
New York	1	March 4, 2026
Florida	1	February 10, 2026
Belgium	1	August 29, 2025
Illinois	1	August 11, 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.