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
63313–63336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2006
QUADROSTAR 532
K060457 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 26d
Cleared Mar 20, 2006
QUADROSTAR 980
K060459 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 26d
Cleared Mar 20, 2006
VECTORVISION HIP
K060468 · HAW
Brainlab AG
Neurology · 25d
Cleared Mar 17, 2006
SPINE-FIX BIOMIMETIC BONE CEMENT
K043593 · NDN
Teknimed, S.A.
Orthopedic · 443d
Cleared Mar 17, 2006
OSTEOPORE PCL SCAFFOLD
K051093 · GXP
Osteopore, Inc.
Neurology · 323d
Cleared Mar 17, 2006
TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
K051542 · FRO
Triosyn Corp.
General & Plastic Surgery · 280d
Cleared Mar 17, 2006
EYEPORT VISION TRAINING SYSTEM
K051684 · NXR
Exercise Your Eyes, Inc.
Ophthalmic · 267d
Cleared Mar 17, 2006
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
K052785 · NUH
Well-Life Healthcare Limited
Neurology · 165d
Cleared Mar 17, 2006
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
K053345 · LJS
Medcomp
General Hospital · 105d
Cleared Mar 17, 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
K053587 · LZO
Ortho Development Corp.
Orthopedic · 84d
Cleared Mar 17, 2006
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE...
K060173 · FLL
ACON Laboratories, Inc.
General Hospital · 53d
Cleared Mar 17, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND...
K060218 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared Mar 17, 2006
VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE
K060267 · LLZ
Implant Logic Systems, Ltd.
Radiology · 44d
Cleared Mar 17, 2006
TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K060286 · JTN
Oxoid , Ltd.
Microbiology · 42d
Cleared Mar 17, 2006
PANORAMIC, MODEL 200MA
K060424 · MYC
Optos Plc.
Ophthalmic · 28d
Cleared Mar 17, 2006
EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
K060475 · ODB
Olympus Medical Systems Corporation
Radiology · 22d
Cleared Mar 17, 2006
STRYKER PLATING SYSTEM
K060514 · HRS
Howmedica Osteonics Corp.
Orthopedic · 18d
Cleared Mar 17, 2006
QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS
K060531 · ITI
Sunrise Medical
Physical Medicine · 17d
Cleared Mar 17, 2006
BIOGRAPH 64 AND BIOGRAPH 40
K060631 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 8d
Cleared Mar 16, 2006
EMD THERMOGRAPHY SYSTEM
K050239 · LHQ
Em Diagnostics, Inc.
Radiology · 407d
Cleared Mar 16, 2006
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
K051675 · MNW
Biodynamics Corp.
Gastroenterology & Urology · 266d
Cleared Mar 16, 2006
SPIROLAB, SPIROLAB II
K052140 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 220d
Cleared Mar 16, 2006
IMMOCARE
K052598 · KHE
Care Diagnostic, Inc.
Hematology · 176d
Cleared Mar 16, 2006
LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS...
K052777 · GEX
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 164d