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
32449–32472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2016
MAGNETOM Spectra
K153447 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Mar 31, 2016
AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split...
K153465 · DKZ
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 121d
Cleared Mar 31, 2016
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage...
K153495 · MAX
Ldr Spine USA
Orthopedic · 115d
Cleared Mar 31, 2016
ECHELON Oval V 5.1 MRI System
K153547 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 111d
Cleared Mar 31, 2016
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
K153687 · JWY
Liofilchem S. R. L.
Microbiology · 99d
Cleared Mar 31, 2016
Halyard Black-Orange Powder-Free Nitrile Exam Glove
K153708 · LZA
Halyard Health
General Hospital · 99d
Cleared Mar 31, 2016
Corin TriFit TS Hip
K153772 · MEH
Corin U.S.A. Limited
Orthopedic · 91d
Cleared Mar 31, 2016
Abutment for Bridges
K153779 · NHA
Altatec GmbH
Dental · 91d
Cleared Mar 31, 2016
PRECICE Trauma Nail System
K160267 · HSB
Ellipse Technologies, Incorporated
Orthopedic · 58d
Cleared Mar 31, 2016
Proxis Ureteral Access Sheath
K160861 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 2d
Cleared Mar 30, 2016
Flight 60 Ventilator
K143035 · CBK
Flight Medical Innovations , Ltd.
Anesthesiology · 525d
Cleared Mar 30, 2016
da Vinci Surgical System, Model IS4000
K152578 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 202d
Cleared Mar 30, 2016
AVIVO Mobile Patient Management (MPM) System
K153160 · MHX
Medtronic, Inc.
Cardiovascular · 149d
Cleared Mar 30, 2016
BrightMatter Guide with Surface Trace Registration
K153281 · HAW
Synaptive Medical, Inc.
Neurology · 139d
Cleared Mar 30, 2016
Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
K153389 · ILY
In Light Wellness Systems, Inc.
Physical Medicine · 128d
Cleared Mar 30, 2016
Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
K160620 · KPR
Visaris D.O.O. Belgrade
Radiology · 26d
Cleared Mar 30, 2016
Rotatable Snares
K160637 · FDI
Boston Scientific Corporation
Gastroenterology & Urology · 23d
Cleared Mar 29, 2016
Puritan Bennett 840 Series Ventilator System
K151252 · CBK
Covidien LP
Anesthesiology · 322d
Cleared Mar 29, 2016
Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
K152105 · PNG
Rocket Medical Plc
Gastroenterology & Urology · 244d
Cleared Mar 29, 2016
Synaptive ImageDrive Pro
K153284 · LLZ
Synaptive Medical, Inc.
Radiology · 138d
Cleared Mar 29, 2016
PURE CRYOGEN
K153564 · GEX
Air Liquide Healthcare America...
General & Plastic Surgery · 106d
Cleared Mar 29, 2016
X-cera Zirconia Blanks
K153767 · EIH
Shenzhen Xiangtong Photoelectricity...
Dental · 90d
Cleared Mar 29, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160336 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Mar 29, 2016
SIGNAPioneer
K160621 · LNH
Ge Healthcare
Radiology · 25d