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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
35857–35880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2015
Heated Eye Pad
K142228 · IRT
Digital Heat Corporation
Physical Medicine · 180d
Cleared Feb 09, 2015
OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod...
K142451 · HSB
Merete Medical GmbH
Orthopedic · 160d
Cleared Feb 09, 2015
POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
K142858 · LZA
Careplus (M) Sdn Bhd
General Hospital · 131d
Cleared CT Feb 09, 2015
ENROUTE Transcarotid Neuroprotection System
K143072 · NTE
Silk Road Medical, Inc.
Cardiovascular · 105d
Cleared Feb 09, 2015
Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip...
K143085 · LPH
Stryker Orthopaedics
Orthopedic · 105d
Cleared Feb 09, 2015
ACUSON P500 Diagnostic Ultrasound System
K150050 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Feb 09, 2015
Excia Total Hip System
K150062 · LZO
Aesculap Implant Systems, LLC
Orthopedic · 27d
Cleared Feb 08, 2015
ENDOCAPSULE SOFTWARE 10
K142680 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 142d
Cleared Feb 06, 2015
ULTRASONIC POCKET DOPPLER
K140579 · KNG
Edan Instruments, Inc.
Obstetrics & Gynecology · 337d
Cleared Feb 06, 2015
ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)
K141492 · DTZ
Eurosets S.R.L
Cardiovascular · 246d
Cleared Feb 06, 2015
CLEO PATIENT MONITOR
K142244 · MWI
Infinium Medical
Cardiovascular · 177d
Cleared Feb 06, 2015
Unimed Disposable and Reusable SPO2 Sensors
K142832 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 129d
Cleared Feb 06, 2015
CAAS A-Valve
K143044 · LLZ
Pie Medical Imaging BV
Radiology · 107d
Cleared Feb 06, 2015
Renovis S141 Lumbar Interbody Cage System
K143126 · MAX
Renovis Surgical Technologies
Orthopedic · 98d
Cleared Feb 06, 2015
Nexis osteosynthesis snap-off screws
K143146 · HWC
Novastep
Orthopedic · 95d
Cleared Feb 06, 2015
Nexis osteosynthesis compressive screws
K143229 · HWC
Novastep
Orthopedic · 88d
Cleared Feb 06, 2015
KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System
K143257 · KPR
Medicatech USA
Radiology · 85d
Cleared Feb 06, 2015
VERTEX Reconstruction System
K143471 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Feb 06, 2015
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine...
K143500 · DKZ
Immunalysis Corporation
Toxicology · 58d
Cleared Feb 06, 2015
Kirschner Wires, Steinmann Pins
K143618 · HTY
Zimmer, Inc.
Orthopedic · 49d
Cleared Feb 06, 2015
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation...
K143678 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 44d
Cleared Feb 06, 2015
Zimmer Segmental System XT Components
K150028 · KRO
Zimmer, Inc.
Orthopedic · 30d
Cleared Feb 06, 2015
MD322C8 31.5 Diagnostic Imaging LCD Monitor
K150145 · PGY
Nec Display Solutions , Ltd.
Radiology · 15d
Cleared Feb 05, 2015
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
K141516 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 241d