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
42937–42960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2012
DIGITAL ELECTROCARDIOGRAPH
K122712 · DPS
Shenzhen Biocare Electronics Co., Ltd.
Cardiovascular · 51d
Cleared Oct 25, 2012
FUSELOX LUMBAR INTERBODY FUSION DEVICE
K122956 · MAX
Captiva Spine
Orthopedic · 30d
Cleared Oct 25, 2012
CLICKFINE PEN NEEDLE
K122969 · FMI
P/L Biomedical
General Hospital · 29d
Cleared Oct 25, 2012
CLICKFINE PEN NEEDLE
K122971 · FMI
P/L Biomedical
General Hospital · 29d
Cleared Oct 25, 2012
STEALTH 360 ORBITAL PAD SYSTEM
K122987 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 29d
Cleared Oct 25, 2012
IRMA C02 MODEL 200101
K123043 · CCK
Phasein AB
Anesthesiology · 27d
Cleared Oct 25, 2012
ENSEAL TRIO TISSUE SEALING DEVICE
K123141 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 20d
Cleared Oct 24, 2012
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765 · KHS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 225d
Cleared Oct 24, 2012
INTRAMEDULLARY NAIL SYSTEM
K121312 · HSB
Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 176d
Cleared Oct 24, 2012
ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
K121636 · LPH
Tgm Medical, Inc.
Orthopedic · 142d
Cleared Oct 24, 2012
SHAPEMATCH CUTTING GUIDE
K122053 · MBH
Stryker Corp.
Orthopedic · 103d
Cleared Oct 24, 2012
IMAGEN3D
K122241 · KPS
Cardiovascular Imaging Technologies
Radiology · 89d
Cleared Oct 24, 2012
HOFFMANN 3
K122284 · KTT
Stryker Corp.
Orthopedic · 86d
Cleared Oct 24, 2012
IMAGE-COM 5.0
K122289 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 86d
Cleared Oct 24, 2012
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
K122292 · KWP
Reliance Medical Systems, LLC
Orthopedic · 85d
Cleared Oct 24, 2012
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED...
K122422 · PNG
Care Fusion
Gastroenterology & Urology · 76d
Cleared Oct 24, 2012
CRE FIXED WIRE BALLON DILATION CATHETER
K122924 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Oct 24, 2012
CDC ZIRCONIA BLANKS
K122972 · EIH
Continental Dental Ceramics, Inc....
Dental · 28d
Cleared Oct 24, 2012
BIOMET LATERAL SPACER SYSTEM
K122989 · MAX
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 28d
Cleared Oct 24, 2012
SMITH & NEPHEW SMF HIP STEM
K123012 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 23, 2012
HX-461
K120545 · DXN
Seers Technology Co., Ltd.
Cardiovascular · 243d
Cleared Oct 23, 2012
FORTEX PEDICLE SCREW SYSTEM
K120832 · MNH
X-Spine Systems, Inc.
Orthopedic · 218d
Cleared Oct 23, 2012
RESOLUTE FACET SCREW SYSTEM
K121551 · MRW
Neurostructures, LLC
Orthopedic · 151d
Cleared Oct 23, 2012
PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY...
K121657 · IYE
Proton Systems
Radiology · 140d