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: Cleared only ×
176,076 results
173809–173832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1977
FRACTURE CAST BRACE KIT, PLASTIC
K770898 · HSP
Chase Mfg. Co.
Orthopedic · 66d
Cleared Jul 21, 1977
FRACTURE CAST BRACE, POLY
K770899 · ITM
Chase Mfg. Co.
Physical Medicine · 66d
Cleared Jul 21, 1977
CAST BRWM, FRACTURE
K770900 · ITM
Chase Mfg. Co.
Physical Medicine · 66d
Cleared Jul 21, 1977
PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY
K770942 · JBQ
Pharmaseal Div., Baxter Healthcare Corp.
Hematology · 58d
Cleared Jul 21, 1977
DIAG. OZYRATE GLUCOSE REAG. SET
K771059 · CGA
J.T. Baker Chemical Co.
Chemistry · 38d
Cleared Jul 21, 1977
DIAG. CONDUCTA RATE BUN REAG. SET
K771060 · CDS
J.T. Baker Chemical Co.
Chemistry · 38d
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