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
52489–52512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2009
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
K082699 · MMI
Roche Diagnostics
Chemistry · 338d
Cleared Aug 19, 2009
SPECTRA SP II, SPECTRA DENTA II
K091320 · GEX
Lutronic Corporation
General & Plastic Surgery · 106d
Cleared Aug 19, 2009
K-LASER K-1200, MODEL 12 W
K091497 · ILY
Eltech S.R.L
Physical Medicine · 91d
Cleared Aug 19, 2009
MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
K092232 · FRO
Puricore, Inc.
General & Plastic Surgery · 27d
Cleared Aug 19, 2009
CONTURA CAVITY MAINTENANCE CATHETER
K092323 · JAQ
Senorx, Inc.
Radiology · 15d
Cleared Aug 18, 2009
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
K083031 · BTO
Smiths Medical Asd, Inc.
Anesthesiology · 312d
Cleared Aug 18, 2009
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
K083250 · GZJ
Aa Neuromed Corp.
Neurology · 287d
Cleared Aug 18, 2009
SPECTRA FLUORESCENCE CARIES DETECTION DEVICE
K090169 · NBL
Air Techniques, Inc.
Dental · 207d
Cleared Aug 18, 2009
KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
K090818 · KCT
KARL STORZ Endoscopy-America, Inc.
General Hospital · 146d
Cleared Aug 18, 2009
KODAK 1500 INTRAORAL CAMERA
K091186 · EIA
Carestream Health, Inc.
Dental · 117d
Cleared Aug 18, 2009
DISPOSABLE PRESSURE TRANSDUCER
K091408 · DRS
Shenzhen Ant Hi-Tech Industrial Co.,...
Cardiovascular · 98d
Cleared Aug 18, 2009
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
K091481 · NBW
Eps Bio Technology Corp.
Chemistry · 91d
Cleared Aug 18, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915,...
K091737 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Aug 18, 2009
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD
K091738 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Aug 18, 2009
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909
K091739 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Aug 18, 2009
S. AUREUS PNA FISH
K091827 · NXX
Advandx, Inc.
Microbiology · 60d
Cleared Aug 17, 2009
PATHFAST CK-MB-II, PATHFAST MYO-II
K081360 · JHX
Mitsubishi Kagaku Iatron
Chemistry · 459d
Cleared Aug 17, 2009
AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
K091074 · GEI
Encision, Inc.
General & Plastic Surgery · 125d
Cleared Aug 17, 2009
CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
K091134 · KWQ
Custom Spine, Inc.
Orthopedic · 119d
Cleared Aug 17, 2009
SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200,...
K091533 · JEP
Garrison Dental Solutions
Dental · 83d
Cleared Aug 17, 2009
BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
K091976 · HSB
Biomet Trauma
Orthopedic · 47d
Cleared Aug 17, 2009
TISSU TRANS HARVEST TUBING
K092022 · KYZ
Shippert Medical Technologies Corp.
General Hospital · 42d
Cleared Aug 14, 2009
SCANSCOPE XT SYSTEM
K080564 · NOT
Aperio Technologies
Pathology · 533d
Cleared Aug 14, 2009
LENSX 550 LASER SYSTEM
K082947 · OOE
Lensx Lasers, Inc.
Ophthalmic · 316d