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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
80161–80184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2001
CAVITY VARNISH
K010255 · LBH
Rite-Dent Manufacturing Corp.
Dental · 81d
Cleared Apr 20, 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313 · MMI
Dade Behring, Inc.
Chemistry · 77d
Cleared Apr 20, 2001
DIMENSION CTNI CALIBRATOR
K010314 · JIT
Dade Behring, Inc.
Chemistry · 77d
Cleared Apr 20, 2001
MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042,...
K010341 · GWG
Medtronic PS Medical
Neurology · 74d
Cleared Apr 20, 2001
SONOTOME ULTRASONIC ASPIRATOR TIPS
K010637 · LFL
Synergetics, Inc.
General & Plastic Surgery · 46d
Cleared Apr 20, 2001
SIMPLICITY SOFT QD EASY INFUSION SET
K010788 · FPA
Sterling Medivations, Inc.
General Hospital · 36d
Cleared Apr 20, 2001
SYNPLUG
K010840 · LZN
Isotis NV
Orthopedic · 30d
Cleared Apr 20, 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880 · DQY
NuMED, Inc.
Cardiovascular · 28d
Cleared Apr 20, 2001
BEAUTIFIL
K010914 · EBF
Shofu Dental Corp.
Dental · 24d
Cleared Apr 20, 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
K010934 · DIS
Syva Co., Dade Behring, Inc.
Toxicology · 23d
Cleared Apr 20, 2001
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969 · GXD
Stryker Instruments
Neurology · 18d
Cleared Apr 20, 2001
EMIT 2000 GENTAMICIN PLUS ASSAY
K010984 · LCD
Syva Co., Dade Behring, Inc.
Toxicology · 18d
Cleared Apr 20, 2001
SAFESTING AND SAFESTING HUB
K011003 · FPA
Diasol, Inc.
General Hospital · 16d
Cleared Apr 20, 2001
OPTIMA
K011053 · ITI
Medical Industries America, Inc.
Physical Medicine · 14d
Cleared Apr 19, 2001
DISPO-MED 7.6 LITER SHARPS CONTAINER
K003521 · FMI
Master Benefits, Inc.
General Hospital · 156d
Cleared Apr 19, 2001
BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)
K010890 · FMF
Becton, Dickinson and Co.
General Hospital · 24d
Cleared Apr 18, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
K010170 · LPH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Apr 18, 2001
LEAD BLOCKS
K010172 · IXI
Arplay Medical S.A.
Radiology · 90d
Cleared Apr 18, 2001
TRAY ADAPTERS, MULTIPLE
K010174 · IYE
Arplay Medical S.A.
Radiology · 90d
Cleared Apr 18, 2001
SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
K010309 · LFL
Mutoh America Co., Ltd.
General & Plastic Surgery · 76d
Cleared Apr 18, 2001
TEMP SCAN
K010383 · FLL
Tenghi Co., Ltd.
General Hospital · 69d
Cleared Apr 18, 2001
ILT DEFLECTING CATHETER, MODEL C114ND1
K010531 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 54d
Cleared Apr 18, 2001
SIMPLICITY WINGED QD INFUSION SET
K010676 · FPA
Sterling Medivations, Inc.
General Hospital · 43d
Cleared Apr 18, 2001
DORNIR LC-1 CPAP SYSTEM
K010704 · BZD
Prym Medical , Ltd.
Anesthesiology · 40d