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
48889–48912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2010
GAMMA-BSM
K102812 · LYC
Etex Corporation
Dental · 66d
Cleared Dec 03, 2010
MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
K102818 · DQX
Micrus Endovascular Corporation
Cardiovascular · 66d
Cleared Dec 03, 2010
PC ECG
K102854 · DPS
Edan Instruments, Inc.
Cardiovascular · 65d
Cleared Dec 03, 2010
IROOT FS
K102867 · KIF
Innovative Bioceramix, Inc.
Dental · 64d
Cleared Dec 03, 2010
PRODESSE PROADENO
K102952 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 59d
Cleared Dec 03, 2010
PHYSIOFLOW ENDURO
K103283 · DSB
Vasocom, Inc.
Cardiovascular · 28d
Cleared Dec 03, 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
K103314 · GGN
Medtronic, Inc.
Hematology · 23d
Cleared Dec 02, 2010
PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS
K101126 · MBI
Core Essence Orthopaedics, Inc.
Orthopedic · 224d
Cleared Dec 02, 2010
MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES
K101577 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 178d
Cleared Dec 02, 2010
ENVIEW (TM)
K102179 · OCV
Carefusion 2200
Gastroenterology & Urology · 121d
Cleared Dec 02, 2010
EVOLVE EPS ORTHOLOC
K102352 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 105d
Cleared Dec 02, 2010
CONSENSUS TAPERSET HIP SYSTEM
K102399 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 100d
Cleared Dec 02, 2010
PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80)
K102404 · OHP
Ventus Medical, Inc.
Dental · 100d
Cleared Dec 02, 2010
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
K102525 · ONZ
Breathe Technologies, Inc.
Anesthesiology · 91d
Cleared Dec 02, 2010
HYPERQ AD-100 SYSTEM
K102579 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 85d
Cleared Dec 02, 2010
SECRMARK BIOPSY SITE MARKING SYSTEM
K102768 · NEU
Hologic, Inc.
General & Plastic Surgery · 69d
Cleared Dec 02, 2010
ELECTROCARDIOGRAPH
K102830 · DPS
Edan Instruments, Inc.
Cardiovascular · 64d
Cleared Dec 02, 2010
ADHESIVE ELECTRODES
K102842 · GXY
Reno Medical Limited
Neurology · 64d
Cleared Dec 02, 2010
LAMINOPLASY PLATING SYSTEM
K103284 · NQW
Aesculap Implant Systems, Inc.
Orthopedic · 27d
Cleared Dec 01, 2010
CCPOINT
K093908 · NHX
Euro-Diagnostica AB
Immunology · 344d
Cleared Dec 01, 2010
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
K100504 · LZG
Valeritas, LLC
General Hospital · 282d
Cleared Dec 01, 2010
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
K101428 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 194d
Cleared Dec 01, 2010
CONCORDE CURVE SYSTEM
K101923 · MAX
Depuy Spine
Orthopedic · 145d
Cleared Dec 01, 2010
SLEEK OTW PTA CATHETERS
K102035 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 135d