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
70729–70752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2003
POLARIS WR
K031671 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 186d
Cleared Dec 01, 2003
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC...
K032696 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Nov 28, 2003
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
K031374 · GZJ
Besmed Health Business Corp
Neurology · 212d
Cleared Nov 28, 2003
TRIHA +
K031826 · MQV
Teknimed, S.A.
Orthopedic · 168d
Cleared Nov 28, 2003
MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
K032383 · GEX
Curelight, Ltd.
General & Plastic Surgery · 119d
Cleared Nov 28, 2003
PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND...
K032716 · CAH
Portex , Ltd.
General Hospital · 87d
Cleared Nov 28, 2003
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K032865 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 77d
Cleared Nov 28, 2003
MICRUS MICROCOIL SYSTEM
K032872 · HCG
Micrus Corp.
Neurology · 74d
Cleared Nov 28, 2003
POWERED WHEELCHAIR, MODEL FR168W
K033370 · ITI
Freerider Corp
Physical Medicine · 38d
Cleared Nov 28, 2003
CWAS 1000
K033452 · IKN
Fasstech
Neurology · 29d
Cleared Nov 28, 2003
MALIS IRRIGATION MODULE 1000
K033499 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 23d
Cleared Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · LOD
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Nov 28, 2003
ARTHROCARE ARTHROWANDS
K033584 · GEI
Arthrocare Corp.
General & Plastic Surgery · 15d
Cleared Nov 26, 2003
OPTIMESH
K014200 · EZX
Spineology, Inc.
General & Plastic Surgery · 705d
Cleared Nov 26, 2003
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · KWD
Wrightmedicaltechnologyinc
Orthopedic · 300d
Cleared Nov 26, 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · LLZ
Eastman Kodak Company
Radiology · 231d
Cleared Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
K031524 · JAQ
Varian Medical Systems, Inc.
Radiology · 195d
Cleared Nov 26, 2003
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K032087 · HLJ
Keeler Instruments, Inc.
Ophthalmic · 142d
Cleared Nov 26, 2003
RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
K032230 · DQD
Thinklabs, Inc.
Cardiovascular · 128d
Cleared Nov 26, 2003
CEMSTOP CEMENT RESTRICTOR
K032685 · LZN
Teknimed, S.A.
Orthopedic · 89d
Cleared Nov 26, 2003
RENOVA INTERNAL HEX IMPLANT SYSTEM
K032774 · DZE
Lifecore Biomedical, Inc.
Dental · 79d
Cleared Nov 26, 2003
LEGIONELLA PNEUMOPHILA IGG/IGM
K033051 · MJH
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
HERPES GROUP IGG
K033059 · LGC
Trinity Biotech, Inc.
Microbiology · 58d
Cleared Nov 26, 2003
MYCOPLASMA IGG
K033064 · LON
Trinity Biotech USA
Microbiology · 58d