FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
128233–128256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1990
SENSI TOUCH PATIENT EXAM GLOVES (VINYL)
K892078 · LYZ
Taiwan Old Shop Corp.
General Hospital · 283d
Cleared Jan 11, 1990
PATIENT EXAMINATION GLOVES (VINYL)
K892180 · LYZ
Singfar Ent. Co. , Ltd.
General Hospital · 282d
Cleared Jan 11, 1990
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
K893991 · KPO
P & A Co.
Gastroenterology & Urology · 220d
Cleared Jan 11, 1990
TOTAL GALACTOSE
K894011 · KQP
Alpkem Corp.
Chemistry · 219d
Cleared Jan 11, 1990
PVC EXAMINATION GLOVES
K894752 · LYZ
Dan Dong Linsen Plastic Industrial...
General Hospital · 169d
Cleared Jan 11, 1990
ACE WIRE TENSION CLAMP
K894982 · JEC
Buckman Co., Inc.
Orthopedic · 156d
Cleared Jan 11, 1990
BATEMAN UPF II HIP PROSTHESIS SYSTEM
K895120 · KWY
3M Company
Orthopedic · 149d
Cleared Jan 11, 1990
AMICON MINIFILTER PLUS HEMOFILTER
K895405 · KDI
Amicon, Inc.
Gastroenterology & Urology · 126d
Cleared Jan 11, 1990
WELLCOLEX COLOUR SHIGELLA TEST ZC51
K895461 · GNB
Wellcome Diagnostics
Microbiology · 127d
Cleared Jan 11, 1990
MEDICOOL, CONTAINER FOR STORING INSULIN
K895674 · LDQ
Medicool, Inc.
General & Plastic Surgery · 113d
Cleared Jan 11, 1990
SODIUM AND POTASSIUM STANDARD
K895717 · JIX
Data Medical Associates, Inc.
Chemistry · 108d
Cleared Jan 11, 1990
BITOME(TM) BIPOLAR SPHINCTEROTOME
K895842 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 101d
Cleared Jan 11, 1990
WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
K895900 · FCK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Jan 11, 1990
TRIGLYCERIDES TEST KIT
K895952 · CDT
Elite Technology, Inc.
Chemistry · 92d
Cleared Jan 11, 1990
VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE
K895993 · KMK
Vitaphore Corp.
General Hospital · 90d
Cleared Jan 11, 1990
PHOSPHORUS
K895999 · CEO
American Monitor Corp.
Chemistry · 90d
Cleared Jan 11, 1990
ASPARTATE AMINOTRANFERASE (AST)
K896000 · CIT
American Monitor Corp.
Chemistry · 90d
Cleared Jan 11, 1990
VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
K896046 · KMK
Vitaphore Corp.
General Hospital · 86d
Cleared Jan 11, 1990
35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM
K896049 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 85d
Cleared Jan 11, 1990
AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.
K896161 · FPA
3M Company
General Hospital · 79d
Cleared Jan 11, 1990
SKED STRETCHER
K896177 · FPP
Skedco, Inc.
General Hospital · 78d
Cleared Jan 11, 1990
SKED FLOTATION SYSTEM
K896179 · FPP
Skedco, Inc.
General Hospital · 78d
Cleared Jan 11, 1990
CENTURION KLEEN-NEEDLE SYSTEM
K896320 · FMI
Tri-State Hospital Supply Corp.
General Hospital · 71d
Cleared Jan 11, 1990
CMS IV FILTERS
K896333 · FPB
Churchill Medical Systems, Inc.
General Hospital · 69d