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
65809–65832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2005
MYLAB 70 ULTRASOUND IMAGING SYSTEM
K051308 · IYN
Esaote, S.P.A.
Radiology · 13d
Cleared May 31, 2005
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
K043067 · LLL
Bioarray Solutions, Ltd.
Immunology · 204d
Cleared May 31, 2005
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442 · GXI
Stryker Instruments
Neurology · 168d
Cleared May 31, 2005
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
K050638 · MSS
Lenstec, Inc.
Ophthalmic · 81d
Cleared May 31, 2005
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
K050856 · HOY
Ophthocare , Ltd.
Ophthalmic · 56d
Cleared May 31, 2005
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
K051086 · KRR
Smith & Nephew, Inc.
Orthopedic · 33d
Cleared May 31, 2005
MODEL TL-560 POWER SCOOTER
K051116 · INI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 29d
Cleared May 31, 2005
MODEL TL-360 POWER SCOOTER
K051118 · INI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 29d
Cleared May 27, 2005
MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
K033262 · FLD
Gambro Renal Products
Gastroenterology & Urology · 596d
Cleared May 27, 2005
PROCON2
K042431 · KNT
Incontinent Control Devices, Inc.
Gastroenterology & Urology · 261d
Cleared May 27, 2005
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
K042606 · GAQ
Synthes (Usa)
General & Plastic Surgery · 245d
Cleared May 27, 2005
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
K043198 · NUJ
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 190d
Cleared May 27, 2005
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE,...
K043342 · FJI
Gambro Renal Products
Gastroenterology & Urology · 172d
Cleared May 27, 2005
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80...
K050006 · DRQ
C.R. Bard, Inc.
Cardiovascular · 144d
Cleared May 27, 2005
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
K050065 · MVN
Ciba Vision Corporation
Ophthalmic · 135d
Cleared May 27, 2005
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K050146 · DXC
Vascular Solutions, Inc.
Cardiovascular · 123d
Cleared May 27, 2005
BALANCE HIP SYSTEM
K050251 · KWA
Biomet, Inc.
Orthopedic · 113d
Cleared May 27, 2005
ARTHREX BIO-PIN
K050259 · HTY
Arthrex, Inc.
Orthopedic · 113d
Cleared May 27, 2005
SURGI-WRAP MAST BIORESORBABLE SHEET
K050332 · FTL
Mast Biosurgery USA, Inc.
General & Plastic Surgery · 106d
Cleared May 27, 2005
CO VERTEBRAL BODY REPLACEMENT
K050348 · MQP
Scient'X
Orthopedic · 105d
Cleared May 27, 2005
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
K050453 · GEX
Ivoclar Vivadent, Inc.
General & Plastic Surgery · 94d
Cleared May 27, 2005
OMNITECH FULGURATING ELECTRODE
K050454 · FAS
Omnitech Systems, Inc.
Gastroenterology & Urology · 94d
Cleared May 27, 2005
AMT NANOCATH
K050557 · BSO
American Medical Technologies, Inc.
Anesthesiology · 85d
Cleared May 27, 2005
RESO-PAC PERIODONTAL DRESSING
K050658 · EMA
Hager Worldwide, Inc.
Dental · 74d