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
38713–38736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2014
SW-THERM
K131899 · IMJ
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 262d
Cleared Mar 14, 2014
FREND TSH (REAGENT CARTRIDGE)
K131928 · JLW
Nanoentek USA, Inc.
Chemistry · 260d
Cleared Mar 14, 2014
CERCOM II CEMENT
K132393 · EMA
Denali Corporation
Dental · 225d
Cleared Mar 14, 2014
FASTOUCH FIXATION SYSTEM
K132698 · GDW
Via Surgical , Ltd.
General & Plastic Surgery · 197d
Cleared Mar 14, 2014
BG MORSELS
K132805 · MQV
Prosidyan, Inc.
Orthopedic · 189d
Cleared Mar 14, 2014
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
K132944 · KPQ
Ge Hungary Kft
Radiology · 176d
Cleared Mar 14, 2014
SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING
K133227 · IYE
Varian Medical Systems, Inc.
Radiology · 144d
Cleared Mar 14, 2014
HEALTHINTERLINK BEACON
K133252 · DRG
Healthinterlink, LLC
Cardiovascular · 143d
Cleared CT Mar 14, 2014
VOLCANO IFR MODALITY
K133323 · IYO
Volcano Corporation
Radiology · 136d
Cleared Mar 14, 2014
CS 8100 3D
K133406 · OAS
Trophy
Radiology · 128d
Cleared Mar 14, 2014
DIAZYME 25-OH VITAMIN D ASSAY
K133410 · MRG
Diazyme Laboratories
Chemistry · 127d
Cleared Mar 14, 2014
TRINIA
K133608 · EBF
Bicon, LLC
Dental · 109d
Cleared Mar 14, 2014
CERASMART
K133824 · EBF
GC America, Inc.
Dental · 87d
Cleared Mar 14, 2014
STERISPINE LC CAGE
K133893 · MAX
Safe Orthopaedics
Orthopedic · 84d
Cleared Mar 14, 2014
RADIANCE 330 PROTON THERAPY SYSTEM
K134052 · LHN
Protom International, Inc.
Radiology · 73d
Cleared Mar 14, 2014
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K140345 · LJS
C.R. Bard, Inc.
General Hospital · 31d
Cleared Mar 14, 2014
LUMENIS PULSE 120H
K140388 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 28d
Cleared Mar 13, 2014
INTENSIF
K130501 · OUH
Endymed Medical, Ltd.
General & Plastic Surgery · 379d
Cleared Mar 13, 2014
ULTRACONGRUENT INSERT
K132752 · JWH
United Orthopedic Corporation
Orthopedic · 191d
Cleared Mar 13, 2014
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
K133005 · GGP
Instrumentation Laboratory CO
Hematology · 169d
Cleared Mar 13, 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K133015 · KCT
Summit Medical, Inc.
General Hospital · 169d
Cleared Mar 13, 2014
E-Z LINK
K133097 · LHI
Duoject Medical Systems, Inc.
General Hospital · 164d
Cleared Mar 13, 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 146d
Cleared Mar 13, 2014
ARSENAL SPINAL FIXATION SYSTEM
K133221 · NKB
Alphatec Spine, Inc.
Orthopedic · 146d