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
160873–160896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1982
HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM
K820192 · GRP
Hyland Therapeutic Div., Travenol...
Microbiology · 45d
Cleared Mar 11, 1982
MIN-MOLECULE PTH BY RADIOIMMUNOASSAY
K820228 · CEW
Immuno Nuclear Corp.
Chemistry · 43d
Cleared Mar 11, 1982
ABBOTT LABORATORIES B-HCG EIA
K820271 · JHI
Abbott Laboratories
Chemistry · 37d
Cleared Mar 11, 1982
IMMOPHASE B HCG RADIOIMMUNOASSAY
K820321 · JHI
Corning Medical & Scientific
Chemistry · 34d
Cleared Mar 11, 1982
A DENTAL AMALGAM ALLOY (UNNAMED
K820389 · EJJ
Dentsply Intl.
Dental · 29d
Cleared Mar 11, 1982
LIQUIZYME NA+/K+ REAGENT SET
K820395 · JGS
American Research Products Co.
Chemistry · 28d
Cleared Mar 11, 1982
4150 ALPHA AMINO ACID ANALYZER
K820415 · JJF
Lkb Instruments, Inc.
Chemistry · 27d
Cleared Mar 11, 1982
K.D. COLORIMETRIC BLOOD UREA N2 TEST
K820418 · JGZ
King Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 11, 1982
IL 8060 DATA MANAGEMENT SYSTEM
K820427 · JQP
Instrumentation Laboratory CO
Chemistry · 22d
Cleared Mar 11, 1982
CLASS OF CASTING ALLOYS TYPE I OR ALTER
K820432 · EJS
Howmedica Corp.
Dental · 22d
Cleared Mar 11, 1982
CLASS OF CASTING ALLOYS TYPE II OR ALTER
K820433 · EJS
Howmedica Corp.
Dental · 22d
Cleared Mar 11, 1982
CLASS OF CASTING ALLOYS TYPE III OR ALT
K820434 · EJS
Howmedica Corp.
Dental · 22d
Cleared Mar 11, 1982
EMIT-AMD AMIKACIN CONTROL
K820439 · LAS
Syva Co.
Toxicology · 22d
Cleared Mar 11, 1982
HEARING AID
K820445 · ESD
Sage Electronics Products, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 11, 1982
CATHETER, MULTIPLE LUMEN
K820446 · GBP
Dlp, Inc.
General & Plastic Surgery · 21d
Cleared Mar 11, 1982
EMIT-ST URINE CALIBRATOR A (#3A319
K820461 · DKB
Syva Co.
Toxicology · 20d
Cleared Mar 11, 1982
EMIT-ST URINE CONTROLS SET A #3A349
K820462 · DIF
Syva Co.
Toxicology · 20d
Cleared Mar 11, 1982
CHEMSTRIP UG
K820465 · CGA
Biodynamics Corp.
Chemistry · 17d
Cleared Mar 11, 1982
SGOT REAGENT SET
K820466 · CIQ
Anco Medical Reagents & Assoc.
Chemistry · 17d
Cleared Mar 11, 1982
ENZYMATIC CHOLESTEROL REAGENT SYSTEM
K820473 · CHH
American Monitor Corp.
Chemistry · 20d
Cleared Mar 11, 1982
QUINTON Q55 MEDICAL TREADMILL
K820478 · IOL
Quinton, Inc.
Physical Medicine · 17d
Cleared Mar 11, 1982
SGPT REAGENT SET
K820491 · CKD
Anco Medical Reagents & Assoc.
Chemistry · 16d
Cleared Mar 11, 1982
TOTAL LIPID REAGENT SET
K820500 · CFD
Anco Medical Reagents & Assoc.
Chemistry · 16d
Cleared Mar 10, 1982
ANAGO STERILE PRODUCTS
K813097 · KKX
Anago, Inc.
General Hospital · 127d