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
41569–41592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
K122453 · LZA
Industrial Clothings, Ltd.
General Hospital · 235d
Cleared Apr 05, 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · NBW
Abbott Laboratories
Chemistry · 186d
Cleared Apr 05, 2013
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
K123122 · KWS
Cleveland Clinic
Orthopedic · 183d
Cleared Apr 05, 2013
ARTHREX FRACTURE PLATES
K123241 · HRS
Arthrex, Inc.
Orthopedic · 170d
Cleared Apr 05, 2013
HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY
K123243 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 170d
Cleared Apr 05, 2013
CIQ CONTROLLER, CIQ WANDS
K123353 · GEI
ArthroCare Corporation
General & Plastic Surgery · 156d
Cleared Apr 05, 2013
HEALTHY SLEEP APPLIANCE
K123410 · LRK
Healthy Sleep Dental Laboratory
Dental · 151d
Cleared Apr 05, 2013
OLYMPUS ENERGY POWER SYSTEM (EPS)
K123429 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 149d
Cleared Apr 05, 2013
HEARLAB ACA
K123701 · GWJ
Frye Electronics, Inc.
Neurology · 123d
Cleared Apr 05, 2013
NEURO OMEGA SYSTEM
K123796 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 116d
Cleared Apr 05, 2013
FIBROSCAN
K123806 · IYO
Echosens
Radiology · 116d
Cleared Apr 05, 2013
MEPILEX TRANSFER AG
K123892 · FRO
Molnlycke Health Care
General & Plastic Surgery · 108d
Cleared Apr 05, 2013
SENTREX BIOSPONGE MPD
K123961 · KGN
Bionova Medical, Inc.
General & Plastic Surgery · 100d
Cleared Apr 05, 2013
MONSTER SCREW SYSTEM
K124027 · HWC
Apogee Orthosolutions
Orthopedic · 98d
Cleared Apr 05, 2013
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
K130006 · PAI
Cook Biotech Incorporated
Obstetrics & Gynecology · 93d
Cleared Apr 05, 2013
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM
K130044 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Apr 05, 2013
INNOVA EPVISION 2.0, INNOVA EPVISION 2.0
K130069 · LLZ
Ge Healthcare
Radiology · 84d
Cleared Apr 05, 2013
PONTIC PAINT
K130237 · NXC
Reliance Orthodontic Products, Inc.
Dental · 64d
Cleared Apr 05, 2013
NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM
K130308 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 57d
Cleared Apr 05, 2013
LOCKING BONE PLATES AND SCREWS
K130340 · HRS
Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 53d
Cleared Apr 05, 2013
MERETEC CS, CORTICAL SCREWS
K130400 · HWC
Merete Medical GmbH
Orthopedic · 45d
Cleared Apr 05, 2013
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON...
K130469 · JLW
DiaSorin, Inc.
Chemistry · 39d
Cleared Apr 05, 2013
ISOLATOR LINEAR PEN
K130521 · OCL
AtriCure, Inc.
Cardiovascular · 36d
Cleared Apr 05, 2013
MERIT HYDROPHILIC GUIDE WIRE
K130588 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 29d