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

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176,076 results
167641–167664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1980
MEDI-THERM
K800812 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 13d
Cleared Apr 24, 1980
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL
K800813 · JJY
Diagnostic Products Corp.
Chemistry · 13d
Cleared Apr 24, 1980
CHLAMYDOSPORE AGAR
K800818 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 13d
Cleared Apr 24, 1980
AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY
K800820 · DBE
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Apr 24, 1980
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
K800821 · DBM
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Apr 24, 1980
KMA FLOW DIRECTED THERMODILUTION CATHETE
K800836 · KRB
Kma, Inc.
Cardiovascular · 9d
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