FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79393–79416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2001
SMOOTH-FLO CIRCUIT
K010402 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 30d
Cleared Mar 14, 2001
BIOSORBFX AND BIOSORBPDX MESH
K010687 · JEY
Bionx Implants, Inc.
Dental · 6d
Cleared Mar 13, 2001
MEMOGRAPH
K001353 · HBW
Biomedical Ent., Inc.
Neurology · 319d
Cleared Mar 13, 2001
MEMOGRAPH
K001354 · JDR
Biomedical Ent., Inc.
Orthopedic · 319d
Cleared Mar 13, 2001
ULTRASONIC NEBULIZER, MODEL NE-520
K002153 · CAF
Medisana USA, Inc.
Anesthesiology · 239d
Cleared Mar 13, 2001
PRONEB ULTRA MODEL NUMBER 85B0100
K002862 · BTI
Pari Holding Co.
Anesthesiology · 181d
Cleared Mar 13, 2001
GRAMSORB SYNTHETIC ABSORBABLE SUTURE
K003017 · GAM
Gramsmed, LLC
General & Plastic Surgery · 167d
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