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
172969–172992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1977
CHOLESTEROL KIT
K771067 · CHH
Environmental Chemical Specialties
Chemistry · 38d
Cleared Jul 21, 1977
SEQUENTIAL PRESSURE CUFF
K771083 · JOW
Gaymar Industries, Inc.
Cardiovascular · 35d
Cleared Jul 21, 1977
UNIPAK BUN
K771087 · CDW
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK URIC ACID
K771088 · KNK
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK TOTAL BILIRUBIN
K771089 · CIG
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK GLUCOSE
K771091 · CGE
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK TOTAL & DIRECT BILIRUBIN
K771092 · CIG
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK CHOLESTEROL
K771093 · CGO
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK ALBUMIN
K771094 · CIX
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
HEMOGLOBIN ANALYZER & PERFORM. CHECK SET
K771101 · GIG
The Dow Chemical Co.
Chemistry · 31d
Cleared Jul 21, 1977
CLINICARD UV AMYLASE CHEMISTRY
K771131 · JFJ
Harleco
Chemistry · 28d
Cleared Jul 21, 1977
CPK-INT TEST
K771154
Hycel, Inc.
Chemistry · 23d
Cleared Jul 21, 1977
RM VI-HV
K771157 · IMG
Rich-Mar Corp.
Physical Medicine · 23d
Cleared Jul 21, 1977
ORTHOSCOPE
K771200 · HRX
Stryker Corp.
Orthopedic · 16d
Cleared Jul 21, 1977
WALPEO TABLH
K771202 · INQ
Walpeo Corp.
Physical Medicine · 16d
Cleared Jul 21, 1977
CENTRIFICHEM TRIGLYCERIDE CALI. STD.
K771215 · JIT
Union Carbide Corp.
Chemistry · 16d
Cleared Jul 21, 1977
CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET
K771216 · JIT
Union Carbide Corp.
Chemistry · 16d
Cleared Jul 21, 1977
LAS-R TEST PROGRAM
K771226 · CFN
Hyland Therapeutic Div., Travenol...
Chemistry · 20d
Cleared Jul 21, 1977
PACEMAKER & CARDIAC LEAD, BIPOLAR
K771262 · DXY
Arco Medical Products Co.
Cardiovascular · 10d
Cleared Jul 21, 1977
QUADRIPLEGIC MEAT KNIFE
K771274 · ILC
Fred Sammons, Inc.
Physical Medicine · 38d
Cleared Jul 21, 1977
FINGEO EXTENSION SPLINTS
K771287 · IQM
Fred Sammons, Inc.
Physical Medicine · 38d
Cleared Jul 21, 1977
JAMAR DYNAMOMETEO BK-7498
K771288 · HRW
Fred Sammons, Inc.
Neurology · 38d
Cleared Jul 19, 1977
CATHETERS, DRAINAGE
K771048 · FEG
Axiom Medical, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 15, 1977
NF DEVICE
K770517 · KPD
Rpr, Inc.
General Hospital · 119d