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
77161–77184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2002
OSTEONICS SPINAL SYSTEM
K020293 · MNH
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Feb 14, 2002
DISPOSABLE LIGHT HANDLE AND ADAPTOR
K020304 · FTA
Aspen Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Feb 14, 2002
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER...
K020317 · LZA
Sgmp Co., Ltd.
General Hospital · 15d
Cleared Feb 13, 2002
UNI-T SPINAL SYSTEM
K013301 · MNI
Spine Vision, Inc.
Orthopedic · 133d
Cleared Feb 13, 2002
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
K013312 · KWP
Spine Vision, Inc.
Orthopedic · 132d
Cleared Feb 13, 2002
FLOWGUARD DEVICE
K013803 · DPW
Biosonix , Ltd.
Cardiovascular · 90d
Cleared Feb 13, 2002
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
K013979 · KWQ
Spinal Concepts, Inc.
Orthopedic · 72d
Cleared Feb 13, 2002
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES
K013998 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 71d
Cleared Feb 13, 2002
HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
K014073 · FMF
Portex, Inc.
General Hospital · 65d
Cleared Feb 13, 2002
ENDIUS CERVICAL PLATE SYSTEM
K014107 · KWQ
Endius, Inc.
Orthopedic · 62d
Cleared Feb 13, 2002
AOS CANNULATED BONE SCREW SYSTEM
K014185 · HWC
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 55d
Cleared Feb 13, 2002
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH...
K014288 · KGO
Wrp Specialty Products Sdn. Bhd.
General Hospital · 47d
Cleared Feb 13, 2002
OMNIA X/XS ULTRASOUND SYSTEM
K020353 · IYN
Siemens Medical Systems, Inc.
Radiology · 9d
Cleared Feb 13, 2002
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K994055 · FRC
Advanced Sterilization Products
General Hospital · 806d
Cleared Feb 12, 2002
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452 · DPW
Koven Technology, Inc.
Cardiovascular · 362d
Cleared Feb 12, 2002
COBE REVOLUTION
K011835 · KFM
Cobe Cardiovascular, Inc.
Cardiovascular · 245d
Cleared Feb 12, 2002
SENSAID
K011974 · DQA
Sensidyne, Inc.
Anesthesiology · 232d
Cleared Feb 12, 2002
DRG REACTION CHAMBER/SAFETY TIP
K012003 · HEI
Doctor'S Research Group, Inc.
Obstetrics & Gynecology · 230d
Cleared Feb 12, 2002
AEROPEP
K012368 · BWF
Trudell Medical Intl.
Anesthesiology · 201d
Cleared Feb 12, 2002
ORION DIGITAL IMAGING SYSTEM
K012490 · OWB
Infimed, Inc.
Radiology · 193d
Cleared Feb 12, 2002
REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
K012675 · JOW
Adven Medical
Cardiovascular · 182d
Cleared Feb 12, 2002
TWIN PLUS
K012976 · OLV
Grass-Telefactor Divison
Neurology · 160d
Cleared Feb 12, 2002
RUSCH MEMORY BAG
K013872 · GCJ
Rusch Intl.
General & Plastic Surgery · 83d
Cleared Feb 12, 2002
BACFIX SPINAL FIXATION SYSTEM
K013887 · MNH
Spinal Concepts, Inc.
Orthopedic · 81d