Data / FDA device clearances / Obstetrics/Gynecology

Obstetrics/Gynecology device clearances: 223

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

The full list. FDA obstetrics/gynecology device clearances and approvals: 223 rows for $11.15, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 11 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/obstetrics-gynecology, 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 223 device decisions in obstetrics/gynecology (FDA review panel) from November 15, 2024 to October 30, 2026: 196 510(k) clearances and De Novo grants and 27 PMA approvals and supplements, for 142 applicants. The newest, K262066 on October 30, 2026, is Pleiades Device from My123Baby Medical Limited Dba Boost Fertility.

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

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223Decisions
196510(k) and De Novo
27PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 223, 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	K262066	Pleiades Device	My123Baby Medical Limited Dba Boost Fertility	Germany	Substantially Equivalent	510(k) traditional	MQK	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	K262125	Nenesupply Venus Handsfree Breast Pump (NBP001-HF)	Nenesupply Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
October 28, 2026	P250051/S001	Juveena Hydrogel System	Rejoni, Inc.	Massachusetts	30-day notice accepted	PMA 30-day notice	MCN	accessdata.fda.gov
October 26, 2026	K262276	Cyperus	Contrario Medical, Inc.	Texas	Substantially Equivalent	510(k) traditional	MQK	accessdata.fda.gov
October 25, 2026	P240015/S003	Womed Leaf	Womed Sas		Approved	PMA real-time process supplement	MCN	accessdata.fda.gov
October 16, 2026	K261782	MODO DUO Electric Pump (B11621, B11673)	Tomy International, Inc.	Iowa	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
October 9, 2026	K262090	Fertilis microICSI Device	Fertilis Pty, Ltd.	Australia	Substantially Equivalent	510(k) traditional	MQK	accessdata.fda.gov
October 9, 2026	K261234	The D-Tip Denudation Pipette	Allwin Medical Devices, Inc.	California	Substantially Equivalent	510(k) traditional	MQH	accessdata.fda.gov
September 28, 2026	P250051	Juveena Hydrogel System	Rejoni, Inc.	Massachusetts	Approved	PMA original approval	MCN	accessdata.fda.gov
September 25, 2026	K254252	UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver...	Karl Storz SE & CO. KG	Germany	Substantially Equivalent	510(k) traditional	HIH	accessdata.fda.gov
September 24, 2026	K254303	KARL STORZ SUPRALOOP	Karl Storz SE & CO. KG	Delaware	Substantially Equivalent	510(k) traditional	KNF	accessdata.fda.gov
September 23, 2026	K260117	Everslide	Special Situations, LLC	Oklahoma	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
September 21, 2026	K262108	FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant...	Shanghai Personage Hygiene Products Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HIS	accessdata.fda.gov
September 18, 2026	K261736	MAGENTA BLAST	Future Fertility, Inc.	Canada	Substantially Equivalent	510(k) traditional	PBH	accessdata.fda.gov
September 18, 2026	K261102	UNIDRIVE Select System	Karl Storz SE & CO. KG	Germany	Substantially Equivalent	510(k) traditional	HIH	accessdata.fda.gov
September 17, 2026	K254203	Wearable Breast Pump (Model S36)	Shenzhen TPH Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
September 15, 2026	P180032/S024	Cerene® Cryotherapy Device	Channel Medsystems, Inc.	California	30-day notice accepted	PMA 30-day notice	MNB	accessdata.fda.gov
September 8, 2026	K254294	Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A...	Zhejiang Geyi Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HIH	accessdata.fda.gov
September 3, 2026	K261622	Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips...	Philips Consumer Lifestyle B.V.	Netherlands	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
September 3, 2026	K253989	HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU...	Maxigen Biotech, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
September 3, 2026	K253673	Mcare System (MW-20)	Marani Health, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	LQK	accessdata.fda.gov
September 1, 2026	K262774	Wearable breast pump (Model: XN/MD-2249BS, ZFHF)	Guangdong Horigen Mother & Baby Products Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
August 31, 2026	P240015/S002	Womed Leaf	Womed Sas		Approved	PMA real-time process supplement	MCN	accessdata.fda.gov
August 28, 2026	K254261	Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)	Cell Store (beijing) Biotechnology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MQL	accessdata.fda.gov
August 21, 2026	K260643	Cimilre Dual Max	Cimilre Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
August 20, 2026	K261298	Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))	Guangdong Youmeng Electrical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
August 19, 2026	K261083	Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)	CooperSurgical, Inc.	Connecticut	Substantially Equivalent	510(k) traditional	MQG	accessdata.fda.gov
August 19, 2026	K260209	ENDOFLATOR+; Smart Smoke Evacuation	Karl Storz SE & CO. KG	Germany	Substantially Equivalent	510(k) traditional	HIF	accessdata.fda.gov
August 18, 2026	K260984	HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)	Axora Medical, Inc.	Florida	Substantially Equivalent	510(k) traditional	HIH	accessdata.fda.gov
August 10, 2026	K254036	Novii+ Wireless Patch System	Datex Ohmeda, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	HGM	accessdata.fda.gov
August 7, 2026	K261905	BUM Oil	Bumlicious, LLC (DBA Bumlicious)	Florida	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
July 24, 2026	K260259	DiscreetDuo Flow Wearable Breast Pump (Model S3)	Shenzhen TPH Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
July 17, 2026	K253694	Natural Cycles	Natural Cycles Nordic AB	Sweden	Substantially Equivalent	510(k) traditional	PYT	accessdata.fda.gov
July 16, 2026	K261706	Endomat Select (UP220)	Karl Storz Se & Co. KG	Germany	Substantially Equivalent	510(k) traditional	HIG	accessdata.fda.gov
July 14, 2026	K253662	LIXI (LXOSFM1)	Luwi, LLC	Illinois	Substantially Equivalent	510(k) traditional	MSC	accessdata.fda.gov
July 13, 2026	P230002/S002	Minitouch 3.8 Era System (Minitouch System)	Microcube, LLC	California	Approved	PMA 180-day supplement	MNB	accessdata.fda.gov
July 13, 2026	K261199	Wearable Breast Pump (Model S32A)	Shenzhen TPH Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
July 9, 2026	K261177	PINKSLIP Water-Based Personal Lubricant and Moisturizer	Pinkslip, LLC	Montana	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
July 8, 2026	P180032/S023	Cerene® Cryotherapy Device	Channel Medsystems, Inc.	California	Approved	PMA 180-day supplement	MNB	accessdata.fda.gov
July 6, 2026	K261909	Plum Vagiceuticals Vaginal Moisturizing Suppositories	PCCA, Inc.	Texas	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
July 2, 2026	DEN250034	Claria System	Claria Medical, Inc.	California	Unknown	De Novo	SIM	accessdata.fda.gov
June 26, 2026	K250070	Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)	Shenzhen Changkun Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	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	K261025	Wearable breast pump (QY-101, QY-102, QY-108)	Shenzhen Qinyi Electronic Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
June 25, 2026	K252584	Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)	Weyo Surgical Technology , Ltd.	China	Substantially Equivalent	510(k) traditional	HIF	accessdata.fda.gov
June 22, 2026	K254011	Flow Water-Based Personal Lubricant	LBDO Group, Inc.	New York	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
June 18, 2026	K254254	Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)	Shenzhen Root Innovation Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
June 17, 2026	K260538	Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )	Shenzhen Root Innovation Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
June 17, 2026	K253333	Assisted Reproduction Laser System (Model ILS-400M)	Hua Yue Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MRX	accessdata.fda.gov
June 15, 2026	K253121	Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle	Gimbo Medical Technology Shenzhen Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MQE	accessdata.fda.gov
June 12, 2026	K260346	Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)	Polybell (Guangzhou) Limited	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
June 11, 2026	K261292	PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)	PR Personal Care Laboratories	California	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
June 11, 2026	K250129	AViTA Breast Pump	Avita Corporation	Taiwan	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
June 9, 2026	K260864	Mother's Nature W1 Warming Wearable Breast Pump	Shenzhen TPH Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
June 9, 2026	K252914	Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)	Hathor Professional Skincare , Ltd.	Canada	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
June 4, 2026	K260956	Spectra Platinum Mini	Uzinmedicare Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
June 4, 2026	K253020	Strauss Surgical Resection Instruments	American Medical Endoscopy, Inc.	Florida	Substantially Equivalent	510(k) traditional	HIH	accessdata.fda.gov
May 29, 2026	K254300	eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)	Anker Innovations Limited	Hong Kong	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
May 21, 2026	K260068	pjur NATURE Touch, 100 ml	Pjur Group Luxembourg S.A.	Luxembourg	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
May 21, 2026	K254244	Wearable Breast Pump (Model S39)	Shenzhen TPH Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
May 20, 2026	K253911	Derma-2	Neko Health AB	Sweden	Substantially Equivalent	510(k) traditional	LHQ	accessdata.fda.gov
May 15, 2026	K254050	Manual Tissue Removal Device	Suzhou AcuVu Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HIH	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 15, 2026	K250781	Embryo Predict	Alife Health	Massachusetts	Substantially Equivalent	510(k) traditional	PBH	accessdata.fda.gov
May 13, 2026	K254125	Electric Breast Pump (HL-3058 II Pro)	Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
May 4, 2026	K252622	Male Latex Condom HA	Okamoto USA, Inc.	Ohio	Substantially Equivalent	510(k) abbreviated	HIS	accessdata.fda.gov
April 29, 2026	K253914	Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)	Shenzhen Root Innovation Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
April 28, 2026	K260248	Ultra-Fast Warm	Kitazato Corporation	Japan	Substantially Equivalent	510(k) traditional	MQL	accessdata.fda.gov
April 28, 2026	K260194	Vacuum Pump (Model: AD-VPUM-500)	Sheng Sheng Yi (Beijing) Technology Company Limited	China	Substantially Equivalent	510(k) traditional	MQG	accessdata.fda.gov
April 27, 2026	K252748	Pelvic Floor Exerciser (PF01)	Hunan Accurate Bio-Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HIR	accessdata.fda.gov
April 22, 2026	K260239	Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)	Jiangxi AOV Maternity & Baby Products Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
April 16, 2026	K254101	Julva Velvé Water-Based Personal Lubricant	Golden Isles Medical, Inc.	Georgia	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
April 16, 2026	K252318	Insufflator (OPTO-IFL1000)	Guangdong Optomedic Technologies, Inc.	China	Substantially Equivalent	510(k) traditional	HIF	accessdata.fda.gov
April 10, 2026	K253510	Freestyle Mini Hands-free	Medela, LLC	Illinois	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
April 8, 2026	K260033	Wearable Breast Pump (Model S21A)	Shenzhen TPH Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
April 8, 2026	K254258	Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A...	Shenzhen Root Innovation Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
April 7, 2026	K253946	Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9...	Shenzhen Root Innovation Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
April 6, 2026	K250208	SPECTRA Wearable 2	Uzinmedicare Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
April 3, 2026	K252744	Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)	Cixi Ruihong Electric Appliance Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
April 1, 2026	K260007	Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)	Hudi Pharma Srl	Italy	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
March 30, 2026	K252158	Sagami Original 002 Polyurethane Male Condom	Mayer Laboratories	California	Substantially Equivalent	510(k) traditional	MOL	accessdata.fda.gov
March 27, 2026	K251273	Asurys Fluid Management System	Boston Scientific Corporation	Massachusetts	Substantially Equivalent	510(k) traditional	HIG	accessdata.fda.gov
March 20, 2026	K252005	Livi Device	Liviwell, Inc.	New Jersey	Substantially Equivalent	510(k) traditional	HEB	accessdata.fda.gov
March 12, 2026	K252583	Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)	A Cute Baby, Inc.	Utah	Substantially Equivalent	510(k) abbreviated	HGX	accessdata.fda.gov
March 9, 2026	K253934	Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)	Shenzhen Root Innovation Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
March 6, 2026	K253983	Water-based lubricant	Guangzhou Haoyimai Trading Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
March 6, 2026	K252208	JFord Speculum Sleeve	Ford Medtech, LLC	New York	Substantially Equivalent	510(k) traditional	HIB	accessdata.fda.gov
March 4, 2026	K260380	Mendit	Escala Medical, Ltd.	Israel	Substantially Equivalent	510(k) special	PBQ	accessdata.fda.gov
February 26, 2026	K254251	InnovexView (GC146-17, GC150-20, GC155-23)	Shanghai AnQing Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HIH	accessdata.fda.gov
February 26, 2026	K253021	ANNE Maternal	Sibel Health, Inc.	Illinois	Substantially Equivalent	510(k) traditional	HGM	accessdata.fda.gov
February 25, 2026	K251687	Konig Bell Circumcision Clamp	Medline Industries, LP	Illinois	Substantially Equivalent	510(k) traditional	HFX	accessdata.fda.gov
February 20, 2026	K252672	CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)	Casebioscience, Inc.	Canada	Substantially Equivalent	510(k) traditional	MQL	accessdata.fda.gov
February 13, 2026	K253149	Motion InBra (YM-8801) wearable breast pump	Medela, LLC	Illinois	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
February 13, 2026	K252422	Wearable Breast Pump (Model W2)	Shenzhen TPH Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
February 13, 2026	K252420	Wearable Breast Pump (Model W12)	Shenzhen TPH Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
February 12, 2026	P140013/S018	Minerva Endometrial Ablation System	Axora Medical, Inc.	Florida	30-day notice accepted	PMA 30-day notice	MNB	accessdata.fda.gov
February 12, 2026	K253354	Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET...	Guangzhou Hehong Biotech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MQF	accessdata.fda.gov
February 6, 2026	K251423	Spectra S1 Pro; Spectra S2 Pro	Uzinmedicare Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
January 28, 2026	P240015/S001	Womed Leaf	Womed Sas		30-day notice accepted	PMA 30-day notice	MCN	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Shenzhen TPH Technology Co., Ltd.	19	September 17, 2026
Shenzhen Root Innovation Technology Co., Ltd.	9	June 18, 2026
ETHICON, Inc.	8	June 25, 2026
Karl Storz SE & CO. KG	5	September 25, 2026
Channel Medsystems, Inc.	5	September 15, 2026
Womed Sas	4	October 25, 2026
CooperSurgical, Inc.	4	August 19, 2026
Axora Medical, Inc.	4	August 18, 2026
Uzinmedicare Co., Ltd.	4	June 4, 2026
Guangdong Youmeng Electrical Technology Co., Ltd.	3	August 20, 2026
Gimbo Medical Technology Shenzhen Co., Ltd.	3	June 15, 2026
Hathor Professional Skincare , Ltd.	3	June 9, 2026
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.	3	May 13, 2026
Medela, LLC	3	April 10, 2026
Unibeauty (Hubei) Technology Co., Ltd.	3	December 17, 2025
Global Protection Corp.	3	August 8, 2025
Rejoni, Inc.	2	October 28, 2026
Natural Cycles Nordic AB	2	July 17, 2026
Hua Yue Medical Technology Co., Ltd.	2	June 17, 2026
Anker Innovations Limited	2	May 29, 2026

By decision type

Decision type	Decisions	Latest
510(k) traditional	173	October 30, 2026
510(k) special	16	March 4, 2026
PMA 30-day notice	14	October 28, 2026
510(k) abbreviated	6	May 4, 2026
PMA real-time process supplement	5	October 25, 2026
PMA 180-day supplement	4	July 13, 2026
PMA original approval	2	September 28, 2026
PMA special supplement	2	December 18, 2025
De Novo	1	July 2, 2026

By state or country

State or country	Decisions	Latest
China	82	September 21, 2026
California	18	October 9, 2026
New Jersey	13	June 25, 2026
Germany	8	October 30, 2026
Massachusetts	8	October 28, 2026
Canada	7	September 18, 2026
South Korea	7	August 21, 2026
Florida	7	August 18, 2026
Illinois	6	July 14, 2026
Taiwan	5	October 29, 2026
Connecticut	5	August 19, 2026
Sweden	5	July 17, 2026
Texas	4	October 26, 2026
Israel	4	March 4, 2026
Japan	3	April 28, 2026
Georgia	3	April 16, 2026
Utah	3	March 12, 2026
United Kingdom	3	September 19, 2025
Denmark	3	January 31, 2025
New York	2	June 22, 2026
Hong Kong	2	May 29, 2026
Ohio	2	May 4, 2026
Oregon	1	October 29, 2026
Iowa	1	October 16, 2026
Australia	1	October 9, 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.