FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Obstetrics & Gynecology ×
4,507 results
1321–1344 of 4,507
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Aug 25, 2009
CERNER FETALINK (VERSION 1.0)
K091251 · HGM
Cerner Corp.
Obstetrics & Gynecology · 118d
Cleared Aug 21, 2009
MYOSURE ROD LENS HYSTEROSCOPE
K091465 · HIH
Interlace Medical, Inc.
Obstetrics & Gynecology · 95d
Cleared Aug 07, 2009
PHARMAPAC PERSONAL LUBRICANT
K091554 · NUC
Pharmapac, LLC
Obstetrics & Gynecology · 72d
Cleared Aug 04, 2009
RESTORELLE POLYPROPYLENE MESH
K092207 · OTP
Mpathy Medical Devices, Inc.
Obstetrics & Gynecology · 13d
Cleared Jul 29, 2009
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
K092054 · HEB
Tosama D.D.
Obstetrics & Gynecology · 22d
Cleared Jul 21, 2009
EZ HSG CATHETER.FOAMSEAL CATHETER
K083594 · LKF
Obg Products
Obstetrics & Gynecology · 228d
Cleared Jul 15, 2009
SONICAID FM820 AND FM830 ENCORE
K090285 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 160d
Cleared Jun 29, 2009
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
K080365 · HET
NOUVAG AG
Obstetrics & Gynecology · 504d
Cleared Jun 23, 2009
FEMVUE(TM) CATHETER SYSTEM
K083690 · LKF
Femasys, Inc.
Obstetrics & Gynecology · 193d
Cleared May 28, 2009
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
K090071 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 136d
Cleared May 08, 2009
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
K083499 · OTP
Coloplast A/S
Obstetrics & Gynecology · 164d
Cleared May 08, 2009
PELVIC FLOOR REPAIR SYSTEM
K091131 · OTP
Boston Scientific
Obstetrics & Gynecology · 18d
Cleared May 01, 2009
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
K082529 · HIS
Alatech Healthcare, LLC
Obstetrics & Gynecology · 241d
Cleared Apr 29, 2009
COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000)...
K082363 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 254d
Cleared Apr 29, 2009
MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
K091084 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 14d
Cleared Apr 24, 2009
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
K083509 · MQL
Intl., Inc.
Obstetrics & Gynecology · 149d
Cleared Apr 23, 2009
WALGREEN'S PERSONAL LUBRICATING JELLY
K080978 · NUC
Topco Sales
Obstetrics & Gynecology · 381d
Cleared Apr 09, 2009
PAPCONE
K083012 · HHT
Otto Bock Pur Life Science GmbH
Obstetrics & Gynecology · 182d
Cleared Apr 02, 2009
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND...
K090713 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 15d
Cleared Mar 31, 2009
ASCEND
K083722 · OTP
Caldera Medical, Inc.
Obstetrics & Gynecology · 106d
Cleared Mar 31, 2009
OKAMOTO ULTRA THIN
K090259 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 57d
Cleared Mar 30, 2009
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 369d
Cleared Mar 04, 2009
LABORPRO SYSTEM
K081984 · NPB
Trig Medical, Ltd.
Obstetrics & Gynecology · 236d
Cleared Feb 18, 2009
COTTONS 100% NATURAL COTTON TAMPONS
K080733 · HEB
Cottons Pty, Ltd.
Obstetrics & Gynecology · 341d