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
63049–63072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2006
ATRIA 3100, ATRIA 6100
K060167 · DPS
Cardiac Science Corporation
Cardiovascular · 86d
Cleared Apr 19, 2006
FLO-RITE, MODEL 478-1
K060382 · NFB
Ameriflo Corp.
Anesthesiology · 64d
Cleared Apr 19, 2006
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K060636 · KXK
C.R. Bard, Inc.
Radiology · 40d
Cleared Apr 19, 2006
VITELCARE C-TURTLE PATIENT MONITORING SYSTEM
K060712 · MWI
Visual Telecommunications Network, Inc.
Cardiovascular · 34d
Cleared Apr 19, 2006
EVOLVE MODULAR RADIAL HEAD
K060731 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Apr 19, 2006
STRYKER INJECTABLE CEMENT
K060750 · NEA
Stryker Cmf
Ear, Nose, Throat · 29d
Cleared Apr 19, 2006
INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER
K060757 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 29d
Cleared Apr 19, 2006
MODIFICATION TO ENDOTINE RIBBON
K060828 · GAM
Coapt Systems, Inc.
General & Plastic Surgery · 23d
Cleared Apr 19, 2006
PROBEAT WITH MGCS
K060834 · LHN
Hitachi , Ltd.
Radiology · 23d
Cleared Apr 19, 2006
MODEL EC9-4 TRANSDUCER
K060879 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 19d
Cleared Apr 19, 2006
MODIFICATION TO: HI-ART SYSTEM
K060912 · IYE
Tomotherapy Incorporated
Radiology · 16d
Cleared Apr 19, 2006
CAAS MRV VERSION 3.0
K060941 · LLZ
Pie Medical Imaging BV
Radiology · 13d
Cleared Apr 19, 2006
SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020
K060947 · ITX
Boston Scientific Corp
Radiology · 13d
Cleared Apr 19, 2006
ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100
K060962 · OCX
Byrne Medical, Inc.
Gastroenterology & Urology · 12d
Cleared Apr 18, 2006
SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM
K060025 · KWQ
Spinal USA
Orthopedic · 104d
Cleared Apr 18, 2006
KLS MARTIN RIGID FIXATION - STERILE
K060177 · JEY
KLS-Martin L.P.
Dental · 85d
Cleared Apr 18, 2006
CONSERVE PLUS QUADRAFIX ACETABULAR SHELL
K060356 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Apr 18, 2006
RHS
K060438 · JDB
Tornier
Orthopedic · 56d
Cleared Apr 18, 2006
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K060683 · KWP
Endius, Inc.
Orthopedic · 34d
Cleared Apr 18, 2006
SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
K060736 · HWC
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Apr 18, 2006
ELECSYS TSH CALSET W/MODELS 04738551
K060754 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Apr 18, 2006
COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER...
K060804 · FRO
Covalon Technologies, Ltd.
General & Plastic Surgery · 25d
Cleared Apr 18, 2006
JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
K060815 · MIX
Bioform Medical, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 17, 2006
EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF
K052817 · FRN
Universal Medical Technologies
General Hospital · 195d