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
1561–1584 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Dec 21, 2005
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
K051294 · HHK
Femspec LLC
Obstetrics & Gynecology · 217d
Cleared Dec 16, 2005
FC 700 FETAL MONITOR
K043597 · HGM
Bionet Co., Ltd.
Obstetrics & Gynecology · 352d
Cleared Dec 16, 2005
FC 1400 FETAL MONITOR
K043598 · HGM
Bionet Co., Ltd.
Obstetrics & Gynecology · 352d
Cleared Dec 16, 2005
WARMING LIQUID PERSONAL LUBRICANT
K052974 · NUC
Pharmapac, LLC
Obstetrics & Gynecology · 53d
Cleared Dec 15, 2005
YUSHENG DISPOSABLE VAGINAL SPECULUM
K052912 · HIB
Zhejiang Yusheng Medical Instrument...
Obstetrics & Gynecology · 59d
Cleared Dec 12, 2005
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
K051926 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 147d
Cleared Nov 22, 2005
IUI CATHETER, MODEL 9057
K052059 · MQF
Inntec, Inc.
Obstetrics & Gynecology · 116d
Cleared Nov 09, 2005
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
K052314 · HIB
Dynarex Corp.
Obstetrics & Gynecology · 76d
Cleared Nov 01, 2005
EVENFLO ELAN BREAST PUMP
K052909 · HGX
Evenflo Company, Inc.
Obstetrics & Gynecology · 15d
Cleared Oct 17, 2005
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
K052365 · HEE
Rocket Medical Plc
Obstetrics & Gynecology · 49d
Cleared Oct 07, 2005
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
K051742 · MQE
Inntec, Inc.
Obstetrics & Gynecology · 101d
Cleared Oct 04, 2005
FETAL MONITOR, MODELS BT-300 AND BT-200
K052190 · HGM
Bistos Co., Ltd.
Obstetrics & Gynecology · 54d
Cleared Sep 22, 2005
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
K052047 · HGX
Avent America, Inc.
Obstetrics & Gynecology · 55d
Cleared Sep 08, 2005
ZIVF-AIRE
K041952 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 415d
Cleared Sep 07, 2005
WHITTLESTONE EXPRESSER
K051112 · HGX
Whittlestone, Inc.
Obstetrics & Gynecology · 128d
Cleared Sep 02, 2005
MANIPUSEAL
K051160 · HEW
Insitu Systems
Obstetrics & Gynecology · 120d
Cleared Sep 02, 2005
MCCARTNEY ACCESS TUBE
K051594 · HEW
Gynetech Pty. , Ltd.
Obstetrics & Gynecology · 78d
Cleared Aug 31, 2005
O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT
K042915 · NUC
O'My Products Incorporated
Obstetrics & Gynecology · 314d
Cleared Aug 29, 2005
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
K051413 · HGX
Avent America, Inc.
Obstetrics & Gynecology · 90d
Cleared Aug 25, 2005
REMOTE CARE
K050234 · HGM
E.Care Solutions, Inc.
Obstetrics & Gynecology · 205d
Cleared Aug 19, 2005
DIVAS DUAL PLEASURE MALE LATEX CONDOM
K051273 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 94d
Cleared Aug 18, 2005
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K043075 · HGM
Tenacore Holdings, Inc.
Obstetrics & Gynecology · 283d
Cleared Aug 09, 2005
MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX...
K040428 · NUC
R & K International Cosmetics
Obstetrics & Gynecology · 537d
Cleared Aug 05, 2005
UGYTEX SUAL KNIT MESH
K051503 · OTP
Sofradim Production
Obstetrics & Gynecology · 59d