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
148921–148944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1985
EMIT QST N-ACETYLPROCAINAMIDE ASSAY
K851060 · LAN
Syva Co.
Toxicology · 21d
Cleared Apr 04, 1985
COMPARTMENT SYNDROME PRESSURE MONITOR SYS
K844214 · LXC
Stryker Corp.
Orthopedic · 155d
Cleared Apr 04, 1985
KONTRON MINIMON 7134 PATIENT MONITOR
K844215 · DRT
Kontron Instruments, Inc.
Cardiovascular · 155d
Cleared Apr 04, 1985
MATRIX 101 NEGATIVE GALVANIC GENERATOR
K844816 · GEI
Prn Medical
General & Plastic Surgery · 114d
Cleared Apr 04, 1985
ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.
K844988 · DXQ
Ethox Corp.
Cardiovascular · 99d
Cleared Apr 04, 1985
MEDITECH EUROSCANNER M250
K850027 · JAK
Stuart Medical, Inc.
Radiology · 90d
Cleared Apr 04, 1985
TREADMILL E-17
K850044 · IOL
Del Mar Avionics
Physical Medicine · 87d
Cleared Apr 04, 1985
WHEELCHAIR, MECHANICAL
K850064 · IOR
Comaco, Inc.
Physical Medicine · 86d
Cleared Apr 04, 1985
HAND HELD GONIOMETER
K850082 · KQW
Chattanooga Group, Inc.
Neurology · 84d
Cleared Apr 04, 1985
CLINICAL ELECTRONIC THERMOMETERS
K850244 · FLL
Sheridan Catheter Corp.
General Hospital · 72d
Cleared Apr 04, 1985
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR
K850252 · DXY
Telectronics, Inc.
Cardiovascular · 72d
Cleared Apr 04, 1985
TRAVENOL FLO-GARD 500 IV MONITOR
K850710 · FLN
Travenol Laboratories, S.A.
General Hospital · 41d
Cleared Apr 04, 1985
TANDEM SETS I.V.
K850757 · LHI
Acacia, Inc.
General Hospital · 38d
Cleared Apr 04, 1985
NORELCO DIGITAL MODEL 987 THERMOMETER
K851010 · FLL
Philips Park
General Hospital · 23d
Cleared Apr 04, 1985
NORELCO DIGITAL MODEL 970 THERMOMETER
K851075 · FLL
Philips Park
General Hospital · 17d
Cleared Apr 04, 1985
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II
K851081 · DXY
Telectronics, Inc.
Cardiovascular · 17d
Cleared Apr 03, 1985
POLY FLEX IMPLANTABLE PACING LEAD
K802294 · DTB
Intermedics, Inc.
Cardiovascular · 1657d
Cleared Apr 03, 1985
MODEL 486-01 PACEMAKER LEAD
K813135 · DTB
Intermedics, Inc.
Cardiovascular · 1245d
Cleared Apr 03, 1985
MODEL 492-01 PACEMAKER LEAD
K813136 · DTB
Intermedics, Inc.
Cardiovascular · 1245d
Cleared Apr 03, 1985
INTERMEDICS POLYFLEX PACING LEAD #480-01
K820267 · DTB
Intermedics, Inc.
Cardiovascular · 1156d
Cleared Apr 03, 1985
DIMERTEST LATEX
K842277 · GHH
Mabco, Inc.
Hematology · 299d
Cleared Apr 03, 1985
TBM-REAGENT FOR T,B CELL & MONOCYTES
K843062 · LIZ
Bd Becton Dickinson Vacutainer...
Microbiology · 243d
Cleared Apr 03, 1985
ABBOTT TDT EIA
K843908 · CIG
Abbott Laboratories
Chemistry · 182d
Cleared Apr 03, 1985
PROGRAMMABLE PATIENT SIMULATOR
K844464 · DSI
Ramford Labs
Cardiovascular · 134d