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
37057–37080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 2014
SIMEX SUBGLOTTIC ASPIRATION SYSTEM
K141255 · BTA
Simex Medizintechnik GmbH
General & Plastic Surgery · 131d
Cleared Sep 19, 2014
ONE PLUS IMPLANT SYSTEM
K133050 · DZE
Osseofuse, Inc.
Dental · 357d
Cleared Sep 19, 2014
XENMATRIX AB SURGICAL GRAFT
K133223 · PIJ
C.R. Bard, Inc.
General & Plastic Surgery · 333d
Cleared Sep 19, 2014
ENDO SMART
K133298 · EKX
Meta Biomed, Inc.
Dental · 329d
Cleared Sep 19, 2014
LONGBOW SPACER SYSTEM
K133717 · MAX
Life Spine
Orthopedic · 288d
Cleared Sep 19, 2014
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
K133753 · QYX
Infobionic, Inc.
Cardiovascular · 284d
Cleared Sep 19, 2014
APOLLO BALLOON DILATATION CATHETER
K133852 · LOX
Brosmed Medical
Cardiovascular · 274d
Cleared Sep 19, 2014
extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT...
K140634 · OMP
Devon Medical, Inc.
General & Plastic Surgery · 191d
Cleared Sep 19, 2014
XLR8 PLUS (XLR8+)
K141437 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 112d
Cleared Sep 19, 2014
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
K141453 · DQO
Lightlab Imaging, Inc.
Cardiovascular · 109d
Cleared Sep 19, 2014
VANTAGE ELAN
K141472 · LNH
Toshiba America Medical Systems, In.C
Radiology · 108d
Cleared Sep 19, 2014
SURGIMAP
K141669 · LLZ
Nemaris, Inc.
Radiology · 88d
Cleared Sep 19, 2014
CLEAR GUIDE ONE
K141806 · IYO
Clear Guide Medical
Radiology · 78d
Cleared Sep 19, 2014
SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
K141998 · DXQ
Pinghu Sama Medical Packing Co., Ltd.
Cardiovascular · 58d
Cleared Sep 19, 2014
Predicate III Guidewire
K142397 · OCY
Lake Region Medical
Gastroenterology & Urology · 23d
Cleared Sep 19, 2014
Extension Set with BD Q-Syte Luer Access Split Septum
K142527 · FPA
Acacia, Inc.
General Hospital · 11d
Cleared Sep 18, 2014
IROOT FM
K130312 · KIF
Innovative Bioceramix, Inc.
Dental · 588d
Cleared Sep 18, 2014
FIA Blood Glucose Monitoring System (G2)
K131173 · NBW
Hmd Biomedical, Inc.
Chemistry · 511d
Cleared Sep 18, 2014
EBM IDO VIEWER
K140399 · LLZ
Ebm Technologies USA, LLC
Radiology · 212d
Cleared Sep 18, 2014
MIVI 6F GUIDE CATHETER
K140557 · DQY
Mivi, LLC
Cardiovascular · 197d
Cleared Sep 18, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K140613 · PGN
Ellipse Technologies, Inc.
Orthopedic · 192d
Cleared Sep 18, 2014
CORTEX ID SUITE
K141074 · KPS
Ge Medical Systems, LLC
Radiology · 146d
Cleared Sep 18, 2014
DISCOVERY IQ
K141477 · KPS
Ge Medical Systems, LLC
Radiology · 106d
Cleared Sep 18, 2014
DENTAL IMAGING SOFTWARE
K141607 · LLZ
Trophy
Radiology · 94d