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
61345–61368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2006
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
K062850 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Oct 23, 2006
CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
K062916 · JJY
Cliniqa Corporation
Chemistry · 25d
Cleared Oct 20, 2006
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
K061651 · HGI
Apple Medical Corp.
Obstetrics & Gynecology · 129d
Cleared Oct 20, 2006
P.0004 IMPLANTS
K062129 · DZE
Institut Straumann AG
Dental · 86d
Cleared Oct 20, 2006
INTEGRA SL
K062147 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 85d
Cleared Oct 20, 2006
SUPER ORTHODONTIC SCREW
K062156 · DZE
Osstem Implant Co., Ltd.
Dental · 84d
Cleared Oct 20, 2006
OCCLUSION BALLOON
K062202 · DQY
Boston Scientific Corp
Cardiovascular · 80d
Cleared Oct 20, 2006
REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
K062251 · DRF
St Jude Medical
Cardiovascular · 78d
Cleared Oct 20, 2006
IRI INTEGRATED RETINAL IMAGER
K062295 · HKI
Medivision Medical Imaging, Ltd.
Ophthalmic · 74d
Cleared Oct 20, 2006
D-SPECT CARDIAC SCANNER SYSTEM
K062450 · KPS
Spectrum Dynamics , Ltd.
Radiology · 59d
Cleared Oct 20, 2006
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
K062647 · OWB
Omega Medical Imaging, Inc.
Radiology · 44d
Cleared Oct 20, 2006
SAGEMAX Z-BLANK
K062695 · EIH
Sagemax Bioceramics, Inc.
Dental · 39d
Cleared Oct 20, 2006
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID
K062705 · LON
Dade Behring, Inc.
Microbiology · 39d
Cleared Oct 20, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062722 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Oct 20, 2006
BIOLUCENT APPLICATOR KIT
K062830 · JAQ
Biolucent, Inc.
Radiology · 30d
Cleared Oct 20, 2006
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
K062832 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 20, 2006
MODIFICATION TO GLIDESHEATH
K062858 · DYB
Terumo Medical Corp.
Cardiovascular · 25d
Cleared Oct 20, 2006
TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02
K062870 · NFA
Kensey Nash Corp.
Cardiovascular · 25d
Cleared Oct 20, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K062882 · LYZ
Suqian Green Glove Co., Ltd.
General Hospital · 24d
Cleared Oct 20, 2006
SBI CARPAL FUSION PLATE
K062903 · HRS
Small Bone Innovations, Inc.
Orthopedic · 23d
Cleared Oct 19, 2006
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
K060967 · NDQ
Stereotaxis, Inc.
Neurology · 195d
Cleared Oct 19, 2006
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
K061681 · HRY
Biomet Manufacturing Corp
Orthopedic · 126d
Cleared Oct 19, 2006
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
K061863 · HWC
Arthrex, Inc.
Orthopedic · 111d
Cleared Oct 19, 2006
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
K062079 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 90d