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
1681–1704 of 4,507
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Dec 16, 2003
THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
K032909 · HIS
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 90d
Cleared Dec 11, 2003
H/S CATHETER SET
K032835 · LKF
Catheter Research, Inc.
Obstetrics & Gynecology · 91d
Cleared Dec 09, 2003
MONA LISA ASPIRATION NEEDLE
K032208 · MQE
Fertility Technology Resources, Inc.
Obstetrics & Gynecology · 144d
Cleared Dec 02, 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 175d
Cleared Nov 18, 2003
MARINA MEDICAL SILICONE PESSARY
K031463 · HHW
Marina Medical Instruments, Inc.
Obstetrics & Gynecology · 194d
Cleared Nov 14, 2003
KWIKEZE MALE CONDOM APPLICATOR
K031007 · HIS
Condax, LLC
Obstetrics & Gynecology · 228d
Cleared Nov 14, 2003
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV...
K032636 · HEB
Playtex Products, Inc.
Obstetrics & Gynecology · 79d
Cleared Oct 31, 2003
MERCATOR HEALTHCARE MALE LATEX CONDOM
K031369 · HIS
Mercator Healthcare , Ltd.
Obstetrics & Gynecology · 184d
Cleared Oct 30, 2003
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
K033131 · HGX
The First Years, Inc.
Obstetrics & Gynecology · 30d
Cleared Oct 08, 2003
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO...
K032772 · HGM
Hill-Rom Manufacturing, Inc.
Obstetrics & Gynecology · 30d
Cleared Sep 29, 2003
ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00,...
K031974 · HIH
Asap Endoscopic Products GmbH
Obstetrics & Gynecology · 95d
Cleared Sep 23, 2003
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
K030966 · NAJ
Boston Scientific Corp
Obstetrics & Gynecology · 180d
Cleared Sep 17, 2003
FETAL SPIRAL ELECTRODE, MODEL FSE07000
K030691 · HGP
Clinical Innovations, Inc.
Obstetrics & Gynecology · 196d
Cleared Sep 15, 2003
NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
K032566 · HGX
The First Years, Inc.
Obstetrics & Gynecology · 25d
Cleared Sep 12, 2003
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
K030961 · LHD
Microlife Corp.
Obstetrics & Gynecology · 169d
Cleared Sep 03, 2003
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
K032173 · HIL
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 49d
Cleared Aug 29, 2003
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
K030441 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 199d
Cleared Aug 29, 2003
BINDER CO2 INCUBATOR SERIE CB
K032526 · MQG
Binder GmbH
Obstetrics & Gynecology · 14d
Cleared Aug 27, 2003
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60,...
K030525 · MQG
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 189d
Cleared Aug 27, 2003
KENTEX DISPOSABLE VAGINAL SPECULUM
K030693 · HIB
Kentron Health Care, Inc.
Obstetrics & Gynecology · 175d
Cleared Aug 22, 2003
INTERMED ZOOM COLPOSCOPE
K031639 · HEX
Intermed Group, Inc.
Obstetrics & Gynecology · 87d
Cleared Aug 21, 2003
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 30d
Cleared Aug 20, 2003
ISM1+, IMS2+, AND UTM+
K030490 · MQL
Medicult A/S
Obstetrics & Gynecology · 187d
Cleared Aug 14, 2003
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
K032080 · HIL
Rostam , Ltd.
Obstetrics & Gynecology · 38d