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
63601–63624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2006
KORLEX-GR GINGIVAL RETRACTION PASTE
K053329 · MVL
Biotech One, Inc.
Dental · 76d
Cleared Feb 15, 2006
COMFORTLITE NASAL MASK
K053352 · BZD
Respironics, Inc.
Anesthesiology · 75d
Cleared Feb 15, 2006
AESCULAP STERILCONTAINER SYSTEM
K053389 · FRG
Aesculap, Inc.
General Hospital · 72d
Cleared Feb 15, 2006
X-TRA FIL
K053391 · EBF
Voco GmbH
Dental · 72d
Cleared Feb 15, 2006
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
K053566 · MZV
Diazyme Laboratories
Chemistry · 55d
Cleared Feb 15, 2006
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
K053575 · JOW
Hygia Health Services, Inc.
Cardiovascular · 55d
Cleared Feb 15, 2006
OSS-BODIES PROXIMAL TIBIAL SLEEVE
K060131 · KRO
Biomet Manufacturing Corp
Orthopedic · 28d
Cleared Feb 14, 2006
BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
K053099 · NHA
BioHorizons Implant Systems, Inc.
Dental · 103d
Cleared Feb 14, 2006
PERIOGLAS BONE GRAFT PARTICULATE
K053387 · LYC
Novabone Products, LLC
Dental · 71d
Cleared Feb 14, 2006
POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
K053523 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 57d
Cleared Feb 14, 2006
LANDLEX, MODEL P100X
K060042 · INI
Besteam Technology, Inc.
Physical Medicine · 39d
Cleared Feb 14, 2006
LEVELERT II FLUID LEVEL SENSOR
K060123 · FLN
Smith & Nephew, Inc.
General Hospital · 27d
Cleared Feb 13, 2006
LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
K052797 · FYD
Medtek Devices, Inc.
General Hospital · 133d
Cleared Feb 13, 2006
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
K052965 · DRB
Guidant Corporation
Cardiovascular · 115d
Cleared Feb 13, 2006
CI KNEE, CI MI TKR
K052966 · HAW
Brainlab AG
Neurology · 115d
Cleared Feb 13, 2006
CONTOUR II SPINAL SYSTEM
K053070 · MNH
Altiva Corp.
Orthopedic · 104d
Cleared Feb 13, 2006
REPROCESSED COMPRESSION SLEEVES
K053316 · JOW
Alliance Medical Corp.
Cardiovascular · 76d
Cleared Feb 13, 2006
SYNFIX-LR
K053508 · MQP
Synthes Spine Co.Lp
Orthopedic · 59d
Cleared Feb 13, 2006
CYNOSURE PHOTOGENICA V-STAR LASER
K053608 · GEX
Cynosure, Inc.
General & Plastic Surgery · 48d
Cleared Feb 13, 2006
POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
K053657 · LZA
Pt Mahakarya Inti Buana
General Hospital · 70d
Cleared Feb 13, 2006
BASIS SPINAL SYSTEM
K060081 · KWP
Medtronic Sofamor Danek
Orthopedic · 34d
Cleared Feb 13, 2006
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
K060130 · CZP
Beckman Coulter, Inc.
Immunology · 26d
Cleared Feb 13, 2006
SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
K060144 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 25d
Cleared Feb 13, 2006
MARCH HEALTHCARE HEALTH MONITORING KIT
K060194 · DXN
March Healthcare Corporation
Cardiovascular · 19d