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
166801–166824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1980
SERALYZER URIC ACID REAGENT STRIPS -
K800848 · KNK
Miles Laboratories, Inc.
Chemistry · 9d
Cleared Apr 24, 1980
SERIES 602 CKGTM RECORDER
K800851 · DSF
Cardio Kinetics, Inc.
Cardiovascular · 9d
Cleared Apr 24, 1980
MODEL 253-11 CYBERLITH PULSE GENERATOR
K800895 · DXY
Intermedics, Inc.
Cardiovascular · 3d
Cleared Apr 21, 1980
EPR-200 PROGRAMMER MODEL 010
K800376 · KRG
Biotronik Sales, Inc.
Cardiovascular · 60d
Cleared Apr 21, 1980
DISPOSABLE PRE-GELLED ELECTROSURGICAL
K800557 · GEI
Vxtra Corp.
General & Plastic Surgery · 40d
Cleared Apr 21, 1980
MEDICAL COMPARTMENT KNEE PROSTHESIS
K800640 · HSX
Dow Corning Wright
Orthopedic · 28d
Cleared Apr 21, 1980
CADWELL 7200
K800648 · IKN
Cadwell Laboratories, Inc.
Neurology · 28d
Cleared Apr 21, 1980
FELDMAN MINI-SAW, #300000
K800669 · EWQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 21, 1980
MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO
K800720
Macomb Chemical Co.
Chemistry · 21d
Cleared Apr 21, 1980
PRE-PADDED PLASTER/PARIS BAND/SPLINTS
K800752 · ITG
Ortho-Care, Inc.
Physical Medicine · 17d
Cleared Apr 21, 1980
IL MODEL 1303 PH/BLOOD GAS ANALYZER
K800757 · CHL
Instrumentation Laboratory CO
Chemistry · 17d
Cleared Apr 21, 1980
SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT
K800770 · JIT
Sclavo, Inc.
Chemistry · 14d
Cleared Apr 21, 1980
RENCTK
K800774 · CIB
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 14d
Cleared Apr 21, 1980
ALDOCTK-125
K800775 · CJM
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 14d
Cleared Apr 21, 1980
TESTOK-125
K800776 · CDZ
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 14d
Cleared Apr 21, 1980
FETAL BOVINE SERUM
K800781 · KIS
Biolabs, Inc.
Pathology · 13d
Cleared Apr 21, 1980
PATELLAR COMPONENT FOR LUBINUS PATELLAR
K800800 · HTG
Waldemar Link GmbH & Co. KG
Orthopedic · 11d
Cleared Apr 21, 1980
I.C.S. MINI & SMALL FRAGMENT SET
K800806 · HRS
Howmedica Corp.
Orthopedic · 11d
Cleared Apr 16, 1980
PERITONE
K800191 · HIR
Laurie Ann Kaiser, Ph.D.
Gastroenterology & Urology · 78d
Cleared Apr 16, 1980
USCI BIPOLAR BALLON PACING ELECTRODE
K800298 · LDF
C.R. Bard, Inc.
Cardiovascular · 65d
Cleared Apr 16, 1980
HEMOSAFE
K800346 · GKL
Med Lab Systems, Inc.
Hematology · 61d
Cleared Apr 16, 1980
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II
K800357 · LAS
Ortho Diagnostics, Inc.
Toxicology · 56d
Cleared Apr 16, 1980
Y-TYPE INFUSION SET (2 LEAD)
K800358 · FPA
Haemonetics Corp.
General Hospital · 56d
Cleared Apr 16, 1980
NOMOS-01 PULSE GENERATOR
K800375 · DXY
Biotronik Sales, Inc.
Cardiovascular · 55d