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
1969–1992 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Mar 29, 2001
SHEER THIN AROMAS YELLOW LATEX CONDOM
K004051 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 27, 2001
SHEER THIN AROMAS BLUE LATEX CONDOM
K004016 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 27, 2001
SHEER THIN AROMAS GREEN LATEX CONDOM
K004036 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 89d
Cleared Mar 22, 2001
BLASTASSIST SYSTEM
K003156 · MQL
Medicult A/S
Obstetrics & Gynecology · 163d
Cleared Mar 22, 2001
SYNVITRO FLUSH
K003163 · MQL
Medicult A/S
Obstetrics & Gynecology · 163d
Cleared Mar 22, 2001
SUPRASPERM SYSTEM
K003404 · MQL
Medicult A/S
Obstetrics & Gynecology · 141d
Cleared Mar 21, 2001
WHITTLESTONE BREASTPUMP
K002696 · HGX
Whittlestone, Inc.
Obstetrics & Gynecology · 203d
Cleared Mar 16, 2001
MN-4 COARSE MANIPULATOR
K010298 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 44d
Cleared Mar 15, 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425 · KNF
Hdc Corp.
Obstetrics & Gynecology · 30d
Cleared Mar 09, 2001
SONICAID FM820, SONICAID FM830
K002150 · HGM
Oxford Instruments
Obstetrics & Gynecology · 235d
Cleared Mar 09, 2001
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC...
K003867 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 87d
Cleared Mar 09, 2001
VCF PERSONAL LUBRICANT
K010182 · NUC
Apothecus Pharmaceutical Corp.
Obstetrics & Gynecology · 49d
Cleared Mar 06, 2001
FETAL ASSIST
K002548 · HGM
Huntleigh Diagnostics , Ltd.
Obstetrics & Gynecology · 201d
Cleared Mar 05, 2001
MULTI CARE THERAPEUTIC VIBRATOR
K010096 · KXQ
Multicept A/S
Obstetrics & Gynecology · 53d
Cleared Mar 02, 2001
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT...
K000180 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 407d
Cleared Feb 22, 2001
TAUT-INSUFFLATION NEEDLE
K003703 · HIF
Taut, Inc.
Obstetrics & Gynecology · 83d
Cleared Feb 21, 2001
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
K002912 · HIB
Sterinc
Obstetrics & Gynecology · 156d
Cleared Feb 21, 2001
STRYKER HEATED INSUFFLATOR TUBE SET
K003792 · HIF
Stryker Corp.
Obstetrics & Gynecology · 75d
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