FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138769–138792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 1987
BESTCON/LUBRICATED CONDOMS
K871470 · HIS
Europharmaceutical Corp.
Obstetrics & Gynecology · 113d
Cleared Aug 05, 1987
PHOTOSTAR V-8
K871681 · HEX
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 98d
Cleared Aug 05, 1987
COLPOSTAR V-6
K871683 · HEX
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 98d
Cleared Aug 05, 1987
MODIFIED HUCKSTEP INTRAMEDULLARY NAIL
K871947 · HSB
Downs Surgical , Ltd.
Orthopedic · 78d
Cleared Aug 05, 1987
AMYLASE TEST KIT
K872023 · JFJ
Ciba Corning Diagnostics Corp.
Chemistry · 71d
Cleared Aug 05, 1987
LADY FREE UNSCENTED MENSTRUAL PAD
K872287 · HHD
American Tissue Corp.
Obstetrics & Gynecology · 50d
Cleared Aug 05, 1987
LIPID CONTROL SERUM
K872376 · JJY
Biological Industries
Chemistry · 47d
Cleared Aug 05, 1987
LAURIER NIGHT SAFE EXTRA PROTECTION SANITARY NAP.
K872481 · HHD
Kao Corp.
Obstetrics & Gynecology · 43d
Cleared Aug 05, 1987
AUTO SUTURE STAINLESS STEEL SUTURES*
K872532 · GAO
United States Surgical, A Division of...
General & Plastic Surgery · 40d
Cleared Aug 05, 1987
SERIES D FLOWMETER
K872718 · CAX
Puritan Bennett Corp.
Anesthesiology · 26d
Cleared Aug 05, 1987
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
K872727 · CEP
Serono Diagnostics, Inc.
Chemistry · 28d
Cleared Aug 05, 1987
BINAX IRMA TOTAL BETA-HCG TEST KIT
K872728 · JHI
Binax, Inc.
Chemistry · 28d
Cleared Aug 05, 1987
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE)
K872814 · CAC
Shiley, Inc.
Anesthesiology · 20d
Cleared Aug 04, 1987
BIO-PROMPT(TM)
K870568 · HCC
Physical Health Devices, Inc.
Neurology · 175d
Cleared Aug 04, 1987
UNIPORT MODEL SD-60, SD-70
K870950 · LJT
Healthcare Technologies, Inc.
General Hospital · 147d
Cleared Aug 04, 1987
FETAL CARE MONITOR ANTEPARTUM 1500
K871082 · HGM
Pie Data Medical BV
Obstetrics & Gynecology · 139d
Cleared Aug 04, 1987
NOVAMETRIX MODEL 200 MAGSTIM
K871338 · GWF
Novametrix Medical Systems, Inc.
Neurology · 123d
Cleared Aug 04, 1987
COMPRESSION LEGGING DEVICE
K871889 · LLK
A-T Surgical Mfg. Co., Inc.
General Hospital · 81d
Cleared Aug 04, 1987
UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM
K872031 · LNK
Laser Media
Gastroenterology & Urology · 70d
Cleared Aug 04, 1987
PHORESOR II (TM), MODEL PM700
K872040 · EGJ
Motion Control, Inc.
Physical Medicine · 69d
Cleared Aug 04, 1987
STERICAP STOPCOCK
K872066 · FMG
Stericap Systems
General Hospital · 67d
Cleared Aug 04, 1987
STERICAP ASSEMBLY AND REPLACEMENT TRAY
K872067 · FMG
Stericap Systems
General Hospital · 67d
Cleared Aug 04, 1987
SURECATH-ITP PERCUTANEOUS ACCESS KIT
K872149 · LJT
Titan Medical, Inc.
General Hospital · 61d
Cleared Aug 04, 1987
BIOCOMP 2001 BIOFEEDBACK DEVICE
K872495 · HCC
Biofeedback Research Institute, Inc.
Neurology · 41d