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
31297–31320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2016
Anti-Borrelia burgdorferi US Westernblot (IgG)
K161513 · LSR
Euroimmun US
Microbiology · 84d
Cleared Aug 25, 2016
G Surgical Marksman MIS System
K161516 · NKB
G Surgical, LLC
Orthopedic · 84d
Cleared Aug 24, 2016
XYcor® Expandable Spinal Spacer System
K160646 · MAX
Alphatec Spine, Inc.
Orthopedic · 170d
Cleared Aug 24, 2016
Infrared Forehead Thermometer, FT-100A
K160802 · FLL
Hangzhou Universal Electronic Co., Ltd.
General Hospital · 154d
Cleared Aug 24, 2016
Kyphon HV-R Bone Cement
K160983 · NDN
Medtronic, Inc.
Orthopedic · 139d
Cleared Aug 24, 2016
ResolutionMD
K161130 · LLZ
Calgary Scientific, Inc.
Radiology · 125d
Cleared Aug 24, 2016
SOMATOM Drive
K161196 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Aug 24, 2016
ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and...
K161313 · PND
Arrow International, Inc. (Subsidiary...
General Hospital · 106d
Cleared CT Aug 24, 2016
FFRct
K161772 · PJA
HeartFlow, Inc.
Cardiovascular · 57d
Cleared Aug 23, 2016
KATANA AVENCIA Block
K153476 · EBF
Kuraray Noritake Dental, Inc.
Dental · 265d
Cleared Aug 23, 2016
Cavilon Advanced High Endurance Skin Protectant
K153571 · KMF
3M Healthcare
General & Plastic Surgery · 252d
Cleared Aug 23, 2016
Vantage Titan 1.5T, MRT-1510, V3.6 Software
K160632 · LNH
Toshibamedical Systems Corporation
Radiology · 169d
Cleared Aug 23, 2016
ZION Anterior Cervical Fixation System
K160702 · KWQ
Astura Medical
Orthopedic · 162d
Cleared Aug 23, 2016
GalaSHAPE 3D
K161092 · OOD
Tepha, Inc.
General & Plastic Surgery · 127d
Cleared Aug 23, 2016
HyperSound Tinnitus Module
K161331 · KLW
Turtle Beach Corporation
Ear, Nose, Throat · 103d
Cleared Aug 23, 2016
Accurett
K161615 · GEH
H&O Equipments, Nv/Sa
General & Plastic Surgery · 74d
Cleared Aug 23, 2016
sTMS mini
K161663 · OKP
Eneura, Inc.
Neurology · 68d
Cleared Aug 22, 2016
Double Medical Universal Spine System
K151458 · MNI
Double Medical Technology, Inc.
Orthopedic · 448d
Cleared Aug 22, 2016
Premium Plus C01/C02 LED Curing Light
K153514 · EBZ
Premium Plus International Limited
Dental · 259d
Cleared Aug 22, 2016
H-Max S stem
K160011 · MEH
Lima Corporate S.P.A.
Orthopedic · 231d
Cleared Aug 22, 2016
ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)
K161098 · LPL
Joowon Innovation Co., Ltd.
Ophthalmic · 125d
Cleared Aug 22, 2016
Streamline OCT Occipito-Cervico-Thoracic System
K161498 · NKG
Pioneer Surgical Technology, Inc....
Orthopedic · 82d
Cleared Aug 22, 2016
PathLoc-L MIS Spinal System
K161766 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 56d
Cleared Aug 22, 2016
Werewolf RF20000 Controller, FLOW 50 Wand
K162074 · GEI
ArthroCare Corporation
General & Plastic Surgery · 26d