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
34369–34392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2015
MultiFIX® P Knotless Fixation Device
K151897 · MBI
ArthroCare Corporation
Orthopedic · 27d
Cleared Aug 05, 2015
SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD...
K132929 · NBW
Sd Biosensor, Inc.
Chemistry · 687d
Cleared Aug 05, 2015
CPAP Cannulaide
K143700 · BZD
Salter Labs
Anesthesiology · 224d
Cleared Aug 05, 2015
Titan
K150086 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 202d
Cleared CT Aug 05, 2015
AXIOS Stent with Electrocautery Enhanced Delivery System
K150692 · PCU
Boston Scientific Corp
Gastroenterology & Urology · 140d
Cleared Aug 05, 2015
COMPACT PIEZO LED
K151023 · ELC
Mectron S.P.A.
Dental · 111d
Cleared Aug 05, 2015
NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase...
K151157 · NHA
Straumann USA, LLC
Dental · 96d
Cleared Aug 05, 2015
OPTIS Integrated System Mobile Workstation
K151286 · NQQ
Lightlab Imaging, Inc.
General & Plastic Surgery · 83d
Cleared Aug 05, 2015
SImmetry Sacroiliac Joint Fusion System
K151818 · OUR
Zyga Technology, Inc.
Orthopedic · 30d
Cleared Aug 04, 2015
TheraCal DC
K143292 · EJK
Bisco, Inc.
Dental · 260d
Cleared Aug 04, 2015
Venus Legacy CX
K143554 · PBX
Venus Concept , Ltd.
General & Plastic Surgery · 232d
Cleared Aug 04, 2015
Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse...
K150735 · GEI
Covidien
General & Plastic Surgery · 137d
Cleared Aug 04, 2015
ForeFoot STP System
K150871 · HWC
Tornier, Inc.
Orthopedic · 125d
Cleared Aug 04, 2015
CareView 1500Cw X-ray Flat Panel Detectors
K150929 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 120d
Cleared Aug 04, 2015
NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free,...
K150973 · KGO
Terang Nusa Snd Bhd
General Hospital · 113d
Cleared Aug 04, 2015
Models 2200DR and 1600DR Digital Stationary Radiographic Systems
K151219 · KPR
Beijing Polycon Medical Engineering...
Radiology · 89d
Cleared Aug 04, 2015
Bovie J-Plasma Handpiece
K151325 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 78d
Cleared Aug 04, 2015
Leksell Gamma Knife Icon
K151561 · IWB
Elekta Instrument AB
Radiology · 55d
Cleared Aug 03, 2015
HI-LIGHT, HI-LIGHT PLUS
K140432 · EBZ
Dentall Corporation
Dental · 529d
Cleared Aug 03, 2015
Metallic Locking Bone Plate and Screw
K142943 · HRS
Canwell Medical Co., Ltd.
Orthopedic · 297d
Cleared Aug 03, 2015
Medtronic Confida Brecker Guidewire
K150465 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 161d
Cleared Aug 03, 2015
Metacross RX PTA Balloon Dilitation Catheter
K150865 · DQY
KANEKA Corporation
Cardiovascular · 124d
Cleared Aug 03, 2015
QuantorView
K151687 · LLZ
3Disc Americas
Radiology · 41d
Cleared Jul 31, 2015
DIGITEK TITANIUM ABUTMENT
K141970 · NHA
Digitek Dental Solutions Limited
Dental · 375d