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
793–816 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Mar 03, 2017
Ontex and other proprietary names
K162746 · HEB
Ontex Bvba
Obstetrics & Gynecology · 154d
Cleared Mar 02, 2017
ENDOFLATOR 40, ENDOFLATOR 50
K161554 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 269d
Cleared Feb 24, 2017
Sydney IVF Culture Oil
K170257 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 28d
Cleared Feb 16, 2017
VitriGuard
K162833 · MQK
Origio A/S
Obstetrics & Gynecology · 128d
Cleared Feb 10, 2017
Astroglide Diamond Silicone Gel Personal Lubricant
K163395 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 67d
Cleared Feb 07, 2017
PUREtrace™
K153262 · OSP
Nemo Healthcare BV
Obstetrics & Gynecology · 455d
Cleared Feb 07, 2017
Unicare System, Unicare Manipulator
K163214 · LKF
Clearpath Surgical, Inc.
Obstetrics & Gynecology · 83d
Cleared Jan 23, 2017
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
K161275 · MQH
Research Instruments Limited
Obstetrics & Gynecology · 262d
Cleared Jan 23, 2017
Lifestyles Zero Lubricated Latex Male Condom
K163107 · HIS
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 77d
Cleared Jan 13, 2017
PANPAC DISPOSABLE VACUUM CURETTES
K161106 · HGH
Panpac Medical Corporation
Obstetrics & Gynecology · 269d
Cleared Jan 13, 2017
LELO RESPECT HEX Natural Rubber Latex Condom
K162511 · HIS
Lelo, Inc.
Obstetrics & Gynecology · 127d
Cleared Jan 12, 2017
Meridian M110 Fetal Monitoring System
K161902 · HGM
Mindchild Medical
Obstetrics & Gynecology · 185d
Cleared Jan 09, 2017
Love Alchemy's Love Lotion
K151857 · NUC
Love Alchemy, LLC
Obstetrics & Gynecology · 551d
Cleared Jan 05, 2017
CrossBay IVF Embryo Transfer Catheter Set
K162064 · MQF
Crossbay Medical, Inc.
Obstetrics & Gynecology · 163d
Cleared Dec 21, 2016
NICO Myriad
K161307 · GEI
Nico Corporation
Obstetrics & Gynecology · 225d
Cleared Dec 19, 2016
EVA (Enhanced Visual Assessment) System
K161871 · HEX
Mobileodt , Ltd.
Obstetrics & Gynecology · 165d
Not Cleared Dec 19, 2016
Hem-Avert Perianal Stabilizer
DEN160005 · PNU
Stetrix, Inc.
Obstetrics & Gynecology · 326d
Cleared Dec 14, 2016
Cryotec
K162051 · MQK
Reprolife, Inc.
Obstetrics & Gynecology · 142d
Cleared Dec 12, 2016
U-Blade Veress Needle
K162648 · HIF
Tianjin Uwell Medical Device...
Obstetrics & Gynecology · 81d
Cleared Dec 08, 2016
Proture Double Electric Breast Pump
K162747 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 69d
Cleared Nov 22, 2016
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
K161763 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 148d
Cleared Oct 28, 2016
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing...
K161725 · HGX
Medela, Inc.
Obstetrics & Gynecology · 128d
Cleared Oct 27, 2016
ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
K161065 · HEW
Surgitools Pty , Ltd.
Obstetrics & Gynecology · 195d
Cleared Oct 20, 2016
aoni Natural Rubber Latex Condom
K153016 · HIS
Guangzhou Daming United Rubber...
Obstetrics & Gynecology · 371d