FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Cleared only ×
175,820 results
26065–26088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2018
UNITY Sacroiliac Joint Fixation System
K173201 · OUR
Huvexel Co. , Ltd.
Orthopedic · 206d
Cleared Apr 26, 2018
Intuitive Surgical EndoWrist Vessel Sealer Extend
K173337 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 185d
Cleared Apr 26, 2018
Xpert Xpress Strep A
K173398 · PGX
Cepheid
Microbiology · 177d
Cleared Apr 26, 2018
Beacon EUS Access System
K180037 · FCG
Covidien, LLC
Gastroenterology & Urology · 111d
Cleared Apr 26, 2018
ESG-300, APU-300, Pressure Reducer, MAPC Probes
K180200 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 92d
Cleared Apr 26, 2018
ENNOVATE®
K180433 · NKB
Aesculap Implant Systems, LLC
Orthopedic · 65d
Cleared Apr 26, 2018
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers
K180548 · LJS
C.R. Bard, Inc (Bard Has Joined Bd)
General Hospital · 56d
Cleared Apr 25, 2018
Oniko nail brace
K162525 · MQZ
Begum Saglik Hizmetleri Tibbi...
General & Plastic Surgery · 593d
Cleared Apr 25, 2018
Phasix ST Mesh
K173143 · OWT
C.R. Bard, Inc.
General & Plastic Surgery · 208d
Cleared Apr 25, 2018
StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G...
K173321 · BSP
Teleflex Medical
Anesthesiology · 187d
Cleared Apr 25, 2018
UNiD Patient Specific 3D printed cage
K173782 · MAX
Medicrea International SA
Orthopedic · 133d
Cleared Apr 25, 2018
Rampart One Lumbar Interbody Fusion Device
K180002 · OVD
Spineology, Inc.
Orthopedic · 113d
Cleared Apr 25, 2018
InCore® Lapidus System
K180257 · HWC
Nextremity Solutions, Inc.
Orthopedic · 85d
Cleared Apr 25, 2018
RayStation 7
K180379 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 72d
Cleared Apr 25, 2018
VERITON NM
K180514 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 57d
Cleared Apr 25, 2018
syngo.plaza
K180563 · LLZ
Siemens Healthcare GmbH
Radiology · 51d
Cleared Apr 25, 2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100...
K180616 · HQD
Contamac, Ltd.
Ophthalmic · 48d
Cleared Apr 24, 2018
IMACTIS CT-Navigation system
K162314 · JAK
Imactis, Sas
Radiology · 614d
Cleared Apr 24, 2018
XD880A Ultrasonic Osteotomy Surgical System
K172464 · JDX
Morley Research Consortium
Orthopedic · 253d
Cleared Apr 24, 2018
ZOOM
K172768 · LLZ
Zetta Medical Technologies, LLC
Radiology · 223d
Cleared Apr 24, 2018
trophon2
K173865 · OUJ
Nanosonics Limited
General Hospital · 125d
Cleared Apr 24, 2018
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable...
K180030 · FTL
Medtronic, Inc.
General & Plastic Surgery · 111d
Cleared Apr 24, 2018
neuromate Gen III
K180206 · HAW
Renishaw Mayfield Sarl
Neurology · 90d
Cleared Apr 24, 2018
Reaxon Plus
K180222 · JXI
Medovent GmbH
Neurology · 89d