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
60553–60576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 2007
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
K070010 · QSY
Z-Medica Corporation
General & Plastic Surgery · 22d
Cleared Jan 25, 2007
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER
K070071 · GEX
Omniguide, Inc.
General & Plastic Surgery · 17d
Cleared Jan 25, 2007
INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E,...
K070155 · EFB
Osseo Scientific, LLC
Dental · 8d
Cleared Jan 24, 2007
SOMNOSCREEN
K060708 · MNR
Somnomedics GmbH & Co. KG
Anesthesiology · 314d
Cleared Jan 24, 2007
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
K062765 · GWF
Nuvasive, Inc.
Neurology · 117d
Cleared Jan 24, 2007
CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
K063235 · QPB
Cytori Therapeutics, Inc.
General & Plastic Surgery · 91d
Cleared Jan 24, 2007
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
K063251 · KWA
Zimmer, Inc.
Orthopedic · 89d
Cleared Jan 24, 2007
TOPACS
K063294 · LLZ
Radiological Specialists, Inc.
Radiology · 84d
Cleared Jan 24, 2007
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1...
K063322 · DDG
Dade Behring, Inc.
Immunology · 82d
Cleared Jan 24, 2007
MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
K063774 · NRY
Concentric Medical, Inc.
Neurology · 34d
Cleared Jan 24, 2007
MODIFICATION TO EASYSPINE SYSTEM
K063794 · MNI
Ldr Spine USA
Orthopedic · 33d
Cleared Jan 24, 2007
NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K063821 · CGA
Nova Biomedical Corp.
Chemistry · 29d
Cleared Jan 24, 2007
INTELEPACS
K070080 · LLZ
Intelerad Medical Systems, Inc.
Radiology · 15d
Cleared Jan 24, 2007
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
K070093 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 14d
Cleared Jan 23, 2007
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG...
K060818 · CDZ
Biokit, S.A.
Chemistry · 302d
Cleared Jan 23, 2007
DUET SYSTEM
K061602 · JOY
Bioview , Ltd.
Hematology · 229d
Cleared Jan 23, 2007
LANDLEX, MODEL S403X
K063196 · INI
Besteam Technology, Inc.
Physical Medicine · 95d
Cleared Jan 23, 2007
INION CPS/OTPS FREEDOMPLATE
K063410 · HRS
Inion , Ltd.
Orthopedic · 71d
Cleared Jan 23, 2007
IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)
K063475 · ITI
Imc-Heart Way LLC
Physical Medicine · 68d
Cleared Jan 23, 2007
DEN TEK NIGHTGUARD
K063483 · MQC
Den Tek Oral Care, Inc.
Dental · 67d
Cleared Jan 23, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H
K063508 · JIX
Dade Behring, Inc.
Chemistry · 64d
Cleared Jan 23, 2007
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
K063524 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 62d
Cleared Jan 23, 2007
CF-1
K063717 · HKI
Canon, Inc.
Ophthalmic · 40d
Cleared Jan 23, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVE
K070035 · LYZ
Super Safe Plastic Products Co., Ltd.
General Hospital · 20d