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
151345–151368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1984
TELECTRONICS MODEL 2401
K831697 · DTC
Seamed Corp.
Cardiovascular · 468d
Cleared Sep 04, 1984
CORNING MAGIC CORTISOL RADIOIMMUNO
K841641 · CGR
Corning Medical & Scientific
Chemistry · 137d
Cleared Sep 04, 1984
CT 9800
K841997 · JAK
General Electric Co.
Radiology · 111d
Cleared Sep 04, 1984
CHEMISTRY CONSOLE
K842401 · JQP
Biovation, Inc.
Chemistry · 77d
Cleared Sep 04, 1984
LH RIA
K842445 · CEP
Syncor Intl. Corp.
Chemistry · 75d
Cleared Sep 04, 1984
CLARK PRECISION BLOCK CUTTER, COOLING
K842615 · IXI
Clark Research and Development, Inc.
Radiology · 61d
Cleared Sep 04, 1984
ACE UNIVERSAL TONG
K842680 · HAX
Buckman Co., Inc.
Neurology · 56d
Cleared Sep 04, 1984
LABSYSTEMS FP-901 CHEMISTRY ANALYZER
K842773 · JJE
Labsystems, Inc.
Chemistry · 50d
Cleared Sep 04, 1984
PERCUFIX CATHETER CUFF
K842890 · KOD
Medi-Tech, Inc.
Gastroenterology & Urology · 43d
Cleared Sep 04, 1984
AMERLEX-M TSH RIA
K842948 · JLW
Amersham Corp.
Chemistry · 40d
Cleared Sep 04, 1984
CARDIONOSTICS HOLTER DURA-LITE RECORDE
K842954 · DSH
Cardionostics, Inc.
Cardiovascular · 39d
Cleared Sep 04, 1984
ION SELECTIVE ELECTRODES & REAGENT SYS
K843008 · CEM
American Monitor Corp.
Chemistry · 35d
Cleared Sep 04, 1984
BILIRUBIN ASSAY KIT DIRECT
K843027 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Sep 04, 1984
BILIRUBIN ASSAY KIT - TOTAL
K843032 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Sep 04, 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · JIS
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Sep 04, 1984
CRITIKON HEPARIN-COATED CARDIOVASCULAR
K843141 · LDF
Critikon Company, LLC
Cardiovascular · 26d
Cleared Sep 04, 1984
ND. YAG LASER FOR ENDOBRONCHIAL OBSTRUC
K843228
Endo Lase, Inc.
Cardiovascular · 19d
Cleared Sep 04, 1984
VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC
K843230 · JFH
Ventrex Laboratories, Inc.
Immunology · 18d
Cleared Sep 04, 1984
MINGO LOG 7
K843440 · DJH
Siemens Elema AB
Toxicology
Cleared Aug 31, 1984
SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC
K842483 · EGJ
Santa Barbara Medco, Inc.
Physical Medicine · 67d
Cleared Aug 30, 1984
FERRIS VENT-A-DERM
K840152
Ferris Mfg. Corp.
General & Plastic Surgery · 230d
Cleared Aug 30, 1984
CLOUTIER II TOTAL KNEE W/BEADED SURF
K841517
Zimmer, Inc.
Orthopedic · 140d
Cleared Aug 30, 1984
HESUNG'S BLOOD DONOR SETS
K841561 · BRZ
Amkor Trading Co.
General Hospital · 48d
Cleared Aug 30, 1984
UV 8001K, PUVA 800, PUVA 180/200 1000
K841795 · KGL
Waldmann Lighting Co.
General & Plastic Surgery · 120d