FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
25465–25488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2018
HDR MRI Lumen Marker
K180069 · JAQ
C4 Imaging, LLC
Radiology · 108d
Cleared Apr 27, 2018
QiF Blood and Fluid Warmer
K180154 · LGZ
Quality IN Flow , Ltd.
General Hospital · 98d
Cleared Apr 27, 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES...
K180669 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 44d
Cleared Apr 26, 2018
Summit Hip System
K170339 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 448d
Cleared Apr 26, 2018
2 Face / Face Evolution
K171821 · NFO
Heat IN A Click
Neurology · 311d
Cleared Apr 26, 2018
P50 Series Dental Operative Unit and Accessories
K171872 · EIA
Pelton & Crane
Dental · 307d
Cleared Apr 26, 2018
INFINITY Total Ankle System
K172633 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 237d
Cleared Apr 26, 2018
Astral 100/150
K172875 · CBK
Resmed, Ltd.
Anesthesiology · 217d
Cleared Apr 26, 2018
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile...
K172923 · LZA
Top Glove Sdn. Bhd.
General Hospital · 213d
Cleared Apr 26, 2018
LungVision Tool
K172955 · EOQ
Bodyvision Medical , Ltd.
Ear, Nose, Throat · 212d
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