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
1873–1896 of 4,507
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Jan 07, 2002
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
K012275 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 172d
Cleared Dec 27, 2001
BIOTEQUE VAGINAL PESSARIES
K013289 · HHW
Bioteque America, Inc.
Obstetrics & Gynecology · 86d
Cleared Dec 21, 2001
GLO-SPEC
K013817 · HIB
Sol Weiss MD, Inc.
Obstetrics & Gynecology · 35d
Cleared Dec 20, 2001
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
K013226 · HGY
Evenflo Company, Inc.
Obstetrics & Gynecology · 84d
Cleared Dec 17, 2001
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
K013972 · LKF
Ackard Laboratories
Obstetrics & Gynecology · 14d
Cleared Dec 14, 2001
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
K013401 · MQG
K-Systems, Kivex Biotec , Ltd.
Obstetrics & Gynecology · 60d
Cleared Dec 14, 2001
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
K013703 · MQG
Sanyo North America Corp.
Obstetrics & Gynecology · 36d
Cleared Dec 13, 2001
WET LIGHT PERSONAL MOISTURIZER
K013086 · HIS
Trigg Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Nov 30, 2001
IUI, MODEL 4220
K013501 · MQF
Gynetics Medical Products NV
Obstetrics & Gynecology · 39d
Cleared Nov 30, 2001
EMTRAC
K013536 · MQF
Gynetics Medical Products NV
Obstetrics & Gynecology · 38d
Cleared Nov 28, 2001
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
K012917 · HFW
Dynarex Corp.
Obstetrics & Gynecology · 90d
Cleared Nov 27, 2001
ORALLITE COMPREHENSIVE EXAM TRAY
K012070 · MPU
Trylon Corp.
Obstetrics & Gynecology · 148d
Cleared Nov 19, 2001
SF SH CATHETER, MODEL R65-945
K013437 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 33d
Cleared Nov 19, 2001
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
K013491 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Nov 13, 2001
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 90d
Cleared Nov 09, 2001
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012664 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 88d
Cleared Nov 09, 2001
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012665 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 88d
Cleared Nov 09, 2001
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
K012962 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 66d
Cleared Nov 09, 2001
56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
K012964 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 66d
Cleared Nov 09, 2001
FAS SET #4551
K013497 · MQE
Gynetics Medical Products NV
Obstetrics & Gynecology · 18d
Cleared Oct 26, 2001
NU-SPEC D
K012859 · HIB
Sol Weiss MD, Inc.
Obstetrics & Gynecology · 63d
Cleared Oct 24, 2001
EZ-ON CONDOM
K001974 · MOL
Mayer Laboratories
Obstetrics & Gynecology · 482d
Cleared Oct 23, 2001
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 288d
Cleared Oct 11, 2001
THECURVE, ITEM 507
K012935 · MFD
Select Medical Systems, Inc.
Obstetrics & Gynecology · 41d