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
149713–149736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1985
CORNING CALCIUM PH ANALYZER 634
K844188 · JFP
Corning Medical & Scientific
Chemistry · 101d
Cleared Feb 04, 1985
CORDIA IC
K844294 · DAK
Cordis Corp.
Immunology · 90d
Cleared Feb 04, 1985
EGNELL-LACT B BATTERY-OPERATED BREAST PUMP
K844307 · HGX
Egnell, Inc.
Obstetrics & Gynecology · 98d
Cleared Feb 04, 1985
IREX PS, PORTABLE SCANNER AND 118
K844404 · IYO
Irex Corp.
Radiology · 83d
Cleared Feb 04, 1985
SERATEST ENA(RNP/SM) DETERMINATION
K844743 · LLL
Seragen Diagnostics, Inc.
Immunology · 61d
Cleared Feb 04, 1985
VISION TRIGLYCERIDES
K850031 · CDT
Abbott Laboratories
Chemistry · 28d
Cleared Feb 04, 1985
OXYGEN CONCENTRATOR
K850346 · CAW
Inspiron Corp.
Anesthesiology · 7d
Cleared Feb 02, 1985
ARTERIAL EXTENSION SET
K850088 · FPA
Medical Matrix, Inc.
General Hospital · 22d
Cleared Feb 01, 1985
MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC
K840037 · DSP
Smec, Inc.
Cardiovascular · 393d
Cleared Feb 01, 1985
ARRHYTHMIA SYSTEM AC-11
K841084 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 325d
Cleared Feb 01, 1985
VARIABLE PRIME COBE MEMBRANE LUNG
K842908 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 192d
Cleared Feb 01, 1985
CARDIAC COMPUTER SP1445
K843555 · DXG
Gould, Inc.
Cardiovascular · 144d
Cleared Feb 01, 1985
SEAMED 4000
K843777 · DTE
Seamed Corp.
Cardiovascular · 129d
Cleared Feb 01, 1985
SEAMED MODEL 6000
K843807 · DTE
Seamed Corp.
Cardiovascular · 127d
Cleared Feb 01, 1985
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
K843824 · LGR
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 01, 1985
COBAS REAGENTS PHENOBARBITAL & PHENOBAR
K843825 · LGQ
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 01, 1985
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
K843826 · LGS
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 01, 1985
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
K843827 · LCQ
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 01, 1985
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
K843828 · LFW
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 01, 1985
PULSE-AID DEVICE
K843977 · LIX
James J. Lally
Cardiovascular · 119d
Cleared Feb 01, 1985
AQUAFORM ELECTRODES WITH AQUAPORE
K844023 · GXY
Biostim, Inc.
Neurology · 109d
Cleared Feb 01, 1985
THE MCP-70-SE SYSTEM
K844180 · KQA
Ellis Pharmaceutical Consulting, Inc.
Radiology · 98d
Cleared Feb 01, 1985
RAPID DIAGNOSTIC KIT
K844442 · LIB
Portable Medical Laboratories, Inc.
Microbiology · 77d
Cleared Feb 01, 1985
LARIAT CATHETER
K844598 · DQO
Mallinckrodt Critical Care
Cardiovascular · 67d