Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Obstetrics & Gynecology ×
4,525 results
1369–1392 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Jan 23, 2009
AIRSTRIP OB
K090061 · HGM
Airstrip Technologies, LP
Obstetrics & Gynecology · 14d
Cleared Jan 22, 2009
ENDEARE BREAST PUMP
K081932 · HGX
Hygeia Medical, Inc.
Obstetrics & Gynecology · 199d
Cleared Jan 15, 2009
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K083839 · OTP
C.R. Bard, Inc.
Obstetrics & Gynecology · 23d
Cleared Jan 14, 2009
MODIFICATION TO URESTA PESSARY
K083769 · HHW
Eastmed, Inc.
Obstetrics & Gynecology · 27d
Cleared Jan 09, 2009
BIRTHTRACK (A.K.A. CLM)
K082704 · NPB
Barnev, Ltd.
Obstetrics & Gynecology · 115d
Cleared Jan 07, 2009
NEO-VAGINA SURGERY SET AND ACCESSORIES
K071754 · HDX
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 559d
Cleared Dec 23, 2008
ENDOSCOPIC CO2 REGULATION UNIT UCR
K081173 · HET
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 243d
Cleared Dec 23, 2008
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
K081768 · NAJ
Cook Incorporated
Obstetrics & Gynecology · 186d
Cleared Dec 23, 2008
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K082677 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 99d
Cleared Dec 18, 2008
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED,...
K080172 · MQL
Medicult A/S
Obstetrics & Gynecology · 329d
Cleared Dec 16, 2008
STRYKER VIDEOSCOPE
K082451 · HET
Stryker Endoscopy
Obstetrics & Gynecology · 113d
Cleared Dec 05, 2008
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K081522 · HHT
Bio Nuclear Diagnostics, Inc.
Obstetrics & Gynecology · 189d
Cleared Dec 04, 2008
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS
K082387 · OTP
American Medical Systems
Obstetrics & Gynecology · 107d
Cleared Nov 26, 2008
RAPIDVIT AND RAPIDWARM CLEAVE
K080446 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 281d
Cleared Nov 26, 2008
FETAL & MATERNAL MONITOR, MODEL F6, F9
K082602 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 79d
Cleared Nov 26, 2008
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE,...
K082730 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 69d
Cleared Nov 21, 2008
JARIT HULKA UTERINE TENACULUM FORCEPS
K082349 · HDC
J. Jamner Surgical Instruments, Inc.
Obstetrics & Gynecology · 98d
Cleared Nov 07, 2008
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
K082066 · HFE
Cook Urological, Inc.
Obstetrics & Gynecology · 108d
Cleared Nov 07, 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 81d
Cleared Oct 24, 2008
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
K081413 · HIS
Dailian Latex Company, Ltd.
Obstetrics & Gynecology · 157d
Cleared Oct 15, 2008
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
K081710 · OTP
American Medical Systems
Obstetrics & Gynecology · 120d
Cleared Oct 10, 2008
VITRIFICATION KIT & VITRIFICATION WARMING KIT
K073522 · MQL
Sage In-Vitro Fertilization, Inc.
Obstetrics & Gynecology · 301d
Cleared Oct 09, 2008
URESTA PESSARY
K081385 · HHW
Eastmed, Inc.
Obstetrics & Gynecology · 146d
Cleared Oct 09, 2008
MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY...
K082802 · HGX
Learning Curve Brands Inc. the First...
Obstetrics & Gynecology · 15d