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
71353–71376 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2003
COLTOSOL F
K031752 · EMA
Coltene/Whaledent, Inc.
Dental · 61d
Cleared Aug 05, 2003
PRECISET DAT PLUS I CALIBRATORS
K031775 · DKB
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Aug 05, 2003
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
K031786 · EOX
Vision-Sciences, Inc.
Ear, Nose, Throat · 56d
Cleared Aug 05, 2003
SAFEPRO PLUS SAFETY SYRINGE
K031830 · MEG
Formosa Medical Devices, Inc.
General Hospital · 53d
Cleared Aug 05, 2003
PULPDENT ETCH-RITE ROYALE
K031915 · KLE
Pulpdent Corporation
Dental · 46d
Cleared Aug 05, 2003
TINA-QUANT CRP (LATEX)
K032336 · DCN
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Aug 05, 2003
UNITY NETWORK IS PATIENT VIEWER
K032346 · MSX
Ge Medical Systems Information...
Cardiovascular · 6d
Cleared Aug 04, 2003
GLUCOLEADER VALUE
K023279 · NBW
Hmd Biomedical, Inc.
Chemistry · 307d
Cleared Aug 04, 2003
PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
K023548 · DQY
Velocimed
Cardiovascular · 286d
Cleared Aug 04, 2003
BONESOURCE BVF
K031435 · MQV
Howmedica Osteonics
Orthopedic · 90d
Cleared Aug 04, 2003
SQUEEZE-EASE MAMMOGRAPHY CUSHION
K031574 · IZH
S & S X-Ray Products, Inc.
Radiology · 76d
Cleared Aug 04, 2003
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM...
K031759 · DKZ
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Aug 01, 2003
HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
K012715 · NLF
Hygia Health Services, Inc.
Anesthesiology · 717d
Cleared Aug 01, 2003
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
K014241 · NCX
Alsius Corp.
Neurology · 583d
Cleared Aug 01, 2003
CARDIODIRECT, MODELS 12M, 12I, 12S
K024283 · DPS
Reynolds Medical , Ltd.
Cardiovascular · 221d
Cleared Aug 01, 2003
R 72
K030487 · KPW
Ralco S.R.L.
Radiology · 168d
Cleared Aug 01, 2003
BALL RECORDING ELECTRODE/STIMULATION PROBE
K030517 · GZK
Viasys Healthcare, Inc.
Neurology · 163d
Cleared Aug 01, 2003
GUGLIELMI DETACHABLE COIL (GDC)
K031049 · HCG
Boston Scientific, Target
Neurology · 121d
Cleared Aug 01, 2003
DBT, DYNAMIC BUBBLE TRAP
K031323 · DTM
Convergenza AG
Cardiovascular · 98d
Cleared Aug 01, 2003
ISOLETTE INFANT INCUBATOR, MODEL C2000E
K031387 · FMZ
Hill-Rom Manufacturing, Inc.
General Hospital · 91d
Cleared Aug 01, 2003
XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
K031451 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 86d
Cleared Aug 01, 2003
MEDRAD MANUAL SYRINGE LOADER
K031483 · DXT
Medrad, Inc.
Cardiovascular · 81d
Cleared Aug 01, 2003
SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT...
K031532 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 78d
Cleared Aug 01, 2003
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
K031561 · DQK
Ge Medical Systems Information...
Cardiovascular · 74d