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
1969–1992 of 4,507
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Feb 20, 2001
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
K003608 · HGI
Aesculap, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 09, 2001
(DISPOSABLE) VAGINAL SPECULUM
K003540 · HIB
Feminica, Inc.
Obstetrics & Gynecology · 85d
Cleared Feb 08, 2001
ENVIVE MINIFORMS
K003843 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 58d
Cleared Feb 01, 2001
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
K002042 · HGI
New England Medical Corp.
Obstetrics & Gynecology · 211d
Cleared Feb 01, 2001
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
K010056 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 24d
Cleared Jan 29, 2001
BIOTEQUE VAGINAL DILATOR
K003380 · HDX
Bioteque America, Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 28, 2001
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
K003375 · LTZ
Tecnilatex S.A.
Obstetrics & Gynecology · 90d
Cleared Jan 17, 2001
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
K003278 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 17, 2001
HYALURONIDASE REAGENT, MODEL CAT#2212
K003751 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 43d
Cleared Jan 08, 2001
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 90d
Cleared Dec 28, 2000
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
K001576 · NBV
Prosurg, Inc.
Obstetrics & Gynecology · 220d
Cleared Dec 21, 2000
SERUM PROTEIN SUBSTITUTE
K003734 · MQL
Sage Biopharma
Obstetrics & Gynecology · 17d
Cleared Dec 19, 2000
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K002393 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 134d
Cleared Dec 15, 2000
MTG - MINITUB HEATED STAGE SYSTEMS
K002971 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 84d
Cleared Dec 13, 2000
OVARIAL BIOPSY SET 324102-324108
K003056 · MQE
Labotect Labor-Technik Gottingen
Obstetrics & Gynecology · 73d
Cleared Dec 07, 2000
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
K003448 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 31d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806 · HIG
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 262d
Cleared Nov 22, 2000
CODA INCUBATOR CELLMATE
K001600 · MQG
Intl., Inc.
Obstetrics & Gynecology · 182d
Cleared Nov 22, 2000
MICROMANIPULATOR
K003142 · MQJ
Research Instruments , Ltd.
Obstetrics & Gynecology · 43d
Cleared Nov 22, 2000
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
K003300 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-5A INJECTOR
K003302 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-5B MICROINJECTOR
K003303 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-6 MICROINJECTOR
K003304 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 21, 2000
PURESPERM WASH
K002630 · MQL
Nidacon International AB
Obstetrics & Gynecology · 90d