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
33049–33072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2016
MultiFIX S Ultra Knotless Fixation System
K153669 · MBI
Arthocare Corporation
Orthopedic · 29d
Cleared Jan 15, 2016
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
K143153 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 438d
Cleared Jan 15, 2016
VIVACE Electrosurgical System
K150409 · OUH
Sung Hwan E&B Co.,Ltd
General & Plastic Surgery · 331d
Cleared Jan 15, 2016
BR-ABVS Viewer 1.0
K151075 · LLZ
Taihao Medical, Inc.
Radiology · 268d
Cleared Jan 15, 2016
MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge,...
K151081 · GDW
Cardica, Inc.
General & Plastic Surgery · 268d
Cleared Jan 15, 2016
PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1:...
K151228 · KGO
Emerson & Co. Srl
General Hospital · 253d
Cleared Jan 15, 2016
ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
K151269 · DSI
Lifewatch Technologies , Ltd.
Cardiovascular · 247d
Cleared Jan 15, 2016
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
K151320 · LON
Becton, Dickinson and Company
Microbiology · 242d
Cleared Jan 15, 2016
Falck Medical Multifunction Tonometer, FAT1
K151491 · HKY
Falck Medical, Inc.
Ophthalmic · 226d
Cleared Jan 15, 2016
Renovo Life Hard Carbon Coated Drill Bit
K151661 · HTW
Renovo Life, LLC
Orthopedic · 210d
Cleared Jan 15, 2016
da Vinci Xi Surgical System
K151794 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 198d
Cleared Jan 15, 2016
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle...
K151848 · JDQ
Zimmer, Inc.
Orthopedic · 192d
Cleared Jan 15, 2016
Reprocessed Vessel Sealer
K152134 · NUJ
Sterilmed, Inc.
General & Plastic Surgery · 168d
Cleared Jan 15, 2016
Esophageal Cooling Device
K152450 · PLA
Advanced Cooling Therapy, LLC
Cardiovascular · 140d
Cleared Jan 15, 2016
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
K152522 · LHC
Ecolab, Inc.
General Hospital · 134d
Cleared Jan 15, 2016
InstaClear Lens Cleaner
K152531 · EOB
Gyrus Acmi, Inc.
Ear, Nose, Throat · 134d
Cleared Jan 15, 2016
Spine Wave Gen II Expandable Interbody System
K152620 · MAX
Spine Wave, Inc.
Orthopedic · 123d
Cleared Jan 15, 2016
PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
K152669 · FRG
Pms Tip Teknolojileri Sanayi VE...
General Hospital · 120d
Cleared Jan 15, 2016
DISPOSABLE THERMOMETER PROBE SHEATHS
K152690 · FLL
Pinghu Sama Medical Packing Co., Ltd.
General Hospital · 116d
Cleared Jan 15, 2016
INFX-8000C, V6.20
K152697 · OWB
Toshibamedical Systems Corporation
Radiology · 116d
Cleared Jan 15, 2016
Bovie Disposable Bipolar Ablator
K152777 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 112d
Cleared Jan 15, 2016
HEALTHMYNE
K153289 · LLZ
Healthmyne, Inc.
Radiology · 63d
Cleared Jan 15, 2016
Medtronic Bio-Medicus Adult Cannula Kit
K153598 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jan 15, 2016
Paragon T2 Wand with Integrated Cable
K153675 · GEI
ArthroCare Corporation
General & Plastic Surgery · 25d