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

Filters: Cleared only ×
176,076 results
80521–80544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2001
ASPIRE COVERED STENT AND DELIVERY CATHETER
K003173 · ESW
Vascular Architects, Inc.
Gastroenterology & Urology · 154d
Cleared Mar 13, 2001
N LATEX CYSTATIN C
K003503 · NDY
Dade Behring, Inc.
Chemistry · 120d
Cleared Mar 13, 2001
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
K003614 · GEX
Coherent Star
General & Plastic Surgery · 111d
Cleared Mar 13, 2001
3D-DOCTOR
K003746 · LLZ
Able Software Corp.
Radiology · 99d
Cleared Mar 13, 2001
TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
K003911 · KWP
Terray Corp.
Orthopedic · 84d
Cleared Mar 13, 2001
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
K003947 · LNH
GE Medical Systems
Radiology · 82d
Cleared Mar 13, 2001
BEAM BLOCK TRAYS
K004015 · IYE
Arplay Medical S.A.
Radiology · 76d
Cleared Mar 13, 2001
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM
K010062 · IYE
Arplay Medical S.A.
Radiology · 64d
Cleared Mar 13, 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND...
K010373 · FPA
Sterling Medivations, Inc.
General Hospital · 34d
Cleared Mar 13, 2001
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
K010405 · IYN
Biosound Esaote, Inc.
Radiology · 29d
Cleared Mar 13, 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
K010428 · JJX
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Mar 13, 2001
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
K010437 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Mar 13, 2001
ALPHA DX SYSTEM
K010562 · MMI
First Medical, Inc.
Chemistry · 15d
Cleared Mar 12, 2001
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
K003837 · OXO
Ge Oec Medical Systems
Radiology · 90d
Cleared Mar 12, 2001
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
K010082 · HQE
Dutch Ophthalmic USA, Inc.
Ophthalmic · 61d
Cleared Mar 12, 2001
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY...
K010126 · LPL
Cl-Tinters
Ophthalmic · 55d
Cleared Mar 12, 2001
ERO SCAN OAE TEST SYSTEM
K010165 · EWO
Etymotic Research
Ear, Nose, Throat · 53d
Cleared Mar 12, 2001
ATLAS MULTI-PURPOSE DSA SYSTEM
K010391 · IZI
Cares Built, Inc.
Radiology · 31d
Cleared Mar 12, 2001
ATHENA REMOTE CONTROLLED RF SYSTEM
K010392 · JAA
Cares Built, Inc.
Radiology · 32d
Cleared Mar 12, 2001
APOLLO MOBILE C ARM SYSTEM
K010393 · OXO
Cares Built, Inc.
Radiology · 32d
Cleared Mar 12, 2001
PHILIPS BV PULSERA/ENDURA
K010435 · OWB
Philips Medical Systems, Inc.
Radiology · 27d
Cleared Mar 12, 2001
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K010548 · HAW
Radionics, A Division of Tyco...
Neurology · 14d
Cleared Mar 12, 2001
BD VISIDRAPE OPHTHALMIC DRAPES
K010572 · KKX
Becton, Dickinson and Co.
General Hospital · 14d