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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
150313–150336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 01, 1985
MEDTRONIC MODEL 6912
K844687 · DTD
Medtronic Vascular
Cardiovascular · 60d
Cleared Feb 01, 1985
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
K844767 · CGI
Biotecx Laboratories, Inc.
Chemistry · 56d
Cleared Feb 01, 1985
MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB
K844781 · CHL
Shaban Mfg. Co.
Chemistry · 53d
Cleared Feb 01, 1985
DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER
K844783 · LLZ
Adac Laboratories
Radiology · 53d
Cleared Feb 01, 1985
DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER
K844784 · LLZ
Adac Laboratories
Radiology · 53d
Cleared Feb 01, 1985
SPACELABS SERIES 600 PATIENT MONITORS
K844888 · DRT
Spacelabs, Inc.
Cardiovascular · 46d
Cleared Feb 01, 1985
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE
K845026 · JLS
Amersham Corp.
Chemistry · 36d
Cleared Feb 01, 1985
SOPHEIA/MP CORTISOL EIA KIT
K850008 · CGR
Diagnostic Products Corp.
Chemistry · 30d
Cleared Feb 01, 1985
A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD
K850032 · BSY
Paco Research Corp.
Anesthesiology · 25d
Cleared Feb 01, 1985
SYSTE MATE TIBC HEM NO. 67225
K850128 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 18d