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
56785–56808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2008
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
K080790 · KWP
Theken Spine, LLC
Orthopedic · 40d
Cleared Apr 29, 2008
TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
K080871 · JAQ
Nucletron Corporation
Radiology · 29d
Cleared Apr 29, 2008
KODAK 9000C EXTRAORAL IMAGING SYSTEM
K080889 · MUH
Trophy
Radiology · 29d
Cleared Apr 29, 2008
SMARTSPOT PRIMAX
K080890 · LLZ
Cmt Medical Technologies, Ltd.
Radiology · 29d
Cleared Apr 29, 2008
S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
K080968 · LNH
Esaote, S.P.A.
Radiology · 25d
Cleared Apr 29, 2008
TRANSPOSAL ULTRA SYSTEMS
K081047 · JCX
Dornoch Medical Systems, Inc.
General & Plastic Surgery · 15d
Cleared Apr 29, 2008
GEMINI CONDOR
K081135 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 8d
Cleared Apr 28, 2008
RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
K071867 · ODV
Paragondx, LLC
Toxicology · 297d
Cleared Apr 28, 2008
AESCULAP PRIMELINE CONTAINER LTD.
K073168 · KCT
Aesculap, Inc.
General Hospital · 171d
Cleared Apr 28, 2008
TRANS1 AXIALIF 2-LEVEL OR II SYSTEM
K073643 · KWQ
Trans1 Incorporated
Orthopedic · 124d
Cleared Apr 28, 2008
NACERA Z AND NACERA Z MEDIUM
K080195 · EIH
Doceram Medical Ceramics GmbH
Dental · 94d
Cleared Apr 28, 2008
CAP PLUS, EQUIVABONE, CAP/DBM
K080329 · MBP
Etex Corp.
Orthopedic · 81d
Cleared Apr 28, 2008
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
K080885 · JDI
Medacta International S.A.
Orthopedic · 28d
Cleared Apr 28, 2008
FOX PLUS PTA CATHETER
K080925 · LIT
Abbott Vascular, Inc.
Cardiovascular · 26d
Cleared Apr 25, 2008
NEUROMETRIX ADVANCE
K070109 · JXE
Neurometrix, Inc.
Neurology · 470d
Cleared Apr 25, 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
K071552 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 324d
Cleared Apr 25, 2008
INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
K072932 · OGZ
Infraredx, Inc.
Cardiovascular · 192d
Cleared Apr 25, 2008
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
K073356 · LZG
Medtronic Minimed
General Hospital · 148d
Cleared Apr 25, 2008
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A
K073358 · LLZ
Heeyoung Co., Ltd.
Radiology · 148d
Cleared Apr 25, 2008
IFS LASER SYSTEM
K073404 · GEX
Intra Lase Corp.
General & Plastic Surgery · 143d
Cleared Apr 25, 2008
COMFORTGEL FULL FACE MASK
K073600 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 126d
Cleared Apr 25, 2008
PC ECG 1200W SYSTEM
K080141 · MWI
Norav Medical , Ltd.
Cardiovascular · 94d
Cleared Apr 25, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
K080151 · PNO
Angioscore, Inc.
Cardiovascular · 94d
Cleared Apr 25, 2008
EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL...
K080408 · KTT
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 71d