FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89065–89088 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1998
GALILEO DISPOSABLE ENDOSCOPES
K981928 · GCJ
Galileo Electro-Optics Corp.
General & Plastic Surgery · 65d
Cleared Aug 06, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982011 · KWP
DePuy Orthopaedics, Inc.
Orthopedic · 59d
Cleared Aug 06, 1998
SILON SCAR STRIPS
K982036 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 57d
Cleared Aug 06, 1998
ASLAN SENSOR MODULAR INSTRUMENT
K982287 · GCJ
Aslan Medical Technologies, Ltd.
General & Plastic Surgery · 37d
Cleared Aug 06, 1998
NIDEK LIGHTSCAN
K982295 · GEX
Nidek, Inc.
General & Plastic Surgery · 36d
Cleared Aug 06, 1998
DISETRONIC PENFINE INJECTION PEN NEEDLE
K982399 · FMI
Disetronic Medical Systems
General Hospital · 27d
Cleared Aug 06, 1998
B2-MICROGLOBULIN CONTROL SET SERUM
K982471 · JJX
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Aug 05, 1998
CT 200 ELECTROCARDIOGRAPH
K961798 · DPS
Macquarie Medical Systems
Cardiovascular · 818d
Cleared Aug 05, 1998
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
K971892 · JOW
Biomedical Horizons, Inc.
Cardiovascular · 440d
Cleared Aug 05, 1998
SILIMED VAGINAL STENT
K974479 · KXP
Silimed, LLC
Obstetrics & Gynecology · 252d
Cleared Aug 05, 1998
RESPAIDE
K980052 · CBP
Emergency Filtration Products, Inc.
Anesthesiology · 211d
Cleared Aug 05, 1998
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K980148 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 202d
Cleared Aug 05, 1998
STAT-SIMPLE PYLORI
K980782 · LYR
Saliva Diagnostic Systems, Inc.
Microbiology · 156d
Cleared Aug 05, 1998
BARD QUANTUM SVR MODEL NUMBER H-6440VR
K981628 · DTN
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Aug 05, 1998
S2LO
K981640 · HLI
Odyssey Optical Systems, LLC
Ophthalmic · 89d
Cleared Aug 05, 1998
STABLEMAPR STEERABLE INTRACARDIAC CATHETERS
K981642 · DRF
Medtronic Cardiorhythm
Cardiovascular · 89d
Cleared Aug 05, 1998
AUREX-3
K981704 · KLW
Adm Tronics Unltd, Inc.
Ear, Nose, Throat · 83d
Cleared Aug 05, 1998
SHELHIGH NO-REACT PNEUMOPLEDGETS
K981756 · FTL
Shelhigh, Inc.
General & Plastic Surgery · 79d
Cleared Aug 05, 1998
LIGHT SABER CORE TISSUE NEEDLE
K981796 · KNW
Minrad, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 05, 1998
SILIMED TISSUE EXPANDER
K981852 · LCJ
Silimed, LLC
General & Plastic Surgery · 71d
Cleared Aug 05, 1998
UM-150A
K981908 · GEI
Umeco Union Medical Engineering
General & Plastic Surgery · 65d
Cleared Aug 05, 1998
KELOCATE SHEETING
K982051 · MDA
Allied Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Aug 05, 1998
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
K982236 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 05, 1998
SMOKE EVACUATION ATTACHMENT 130XXX TBD
K982309 · GEI
Conmedcorp
General & Plastic Surgery · 35d