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
162889–162912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 1981
HELENA VMA-SMC CONTROL
K811912 · JJX
Helena Laboratories
Chemistry · 22d
Cleared Jul 23, 1981
I.V. ADMIN. SETS FOR THE AMP MARK IV PMP
K811917 · FRN
American Medical Products, Inc.
General Hospital · 21d
Cleared Jul 23, 1981
KODAK EKTACHEM 400 ANALYZER
K811919 · JJE
Eastman Kodak Company
Chemistry · 21d
Cleared Jul 23, 1981
HITACHI 705 CALIBRATOR
K811921 · JIX
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Jul 23, 1981
45DEGREES SWIVEL ELBOW
K811922 · BZA
Dhd Medical Products Div. Diemolding...
Anesthesiology · 21d
Cleared Jul 23, 1981
COAT-A-COUNT DIGOXIN RIA
K811932 · DPO
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jul 23, 1981
VITATRON 88
K811939 · GZJ
Vitatronics
Neurology · 17d
Cleared Jul 23, 1981
IMMOPHASE INSULIN (125I) RADIOASSAY
K811953 · CFP
Corning Medical & Scientific
Hematology · 15d
Cleared Jul 23, 1981
CAMPYPAK
K811957 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 14d
Cleared Jul 23, 1981
VISITEC NEEDLE RANGE (GENERAL HOSPITAL)
K811966 · FMI
Visitec Co.
General Hospital · 13d
Cleared Jul 23, 1981
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
K812078 · JTY
Abbott Laboratories
Microbiology
Cleared Jul 21, 1981
FREEZE DRIED PAPAIN
K810803 · KSK
Biological Corp. of America
Immunology · 119d
Cleared Jul 21, 1981
OXYGEN CONTROLLER MODEL 145
K812038
Medix Medical Electronics (U.S.A.), Inc.
Cardiovascular
Cleared Jul 20, 1981
ELA MEDICAL UNILITH 7540 PULSE GENERATOR
K810887 · DXY
Ela Medical, Inc.
Cardiovascular · 110d
Cleared Jul 20, 1981
WEBER/STUEHMER HIP JOINT ENDOPROSTHESIS
K811119
Allo Pro Corp.
Orthopedic · 87d
Cleared Jul 20, 1981
PACEMAKER PROGRAMMER #2010
K811217 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 77d
Cleared Jul 20, 1981
CATH-DAP
K811277 · KOD
Northwest Alabama Urological Assoc.
Gastroenterology & Urology · 73d
Cleared Jul 20, 1981
TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880
K811318 · LDF
Medtronic Vascular
Cardiovascular · 69d
Cleared Jul 20, 1981
OXIMETRIX ACCU SAT CPB
K811391 · DRY
Oximetrix, Inc.
Cardiovascular · 63d
Cleared Jul 20, 1981
DEPUY HEMODRAIN
K811557 · GCY
Depuy, Inc.
General & Plastic Surgery · 48d
Cleared Jul 20, 1981
THERMOMETER (MADE IN CHINA)
K811631 · FLK
Robert I. Chien & Assoc., Inc.
General Hospital · 41d
Cleared Jul 20, 1981
SURGICAL INSTRUMENTS
K811686 · GEN
C.V.I., Inc.
General & Plastic Surgery · 35d
Cleared Jul 20, 1981
CORDIS OMNI-ARTICOR CARDIAC PACER #308
K811691 · DXY
Cordis Corp.
Cardiovascular · 35d
Cleared Jul 20, 1981
AXICUT DISPOSABLE SCALPEL
K811707 · GDX
Neonatal Corp.
General & Plastic Surgery · 34d