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

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175,820 results
21217–21240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2019
R&D Series Nova Compo N
K192178 · EBF
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 130d
Cleared Dec 20, 2019
BriefCase
K192383 · QAS
Aidoc Medical , Ltd.
Radiology · 112d
Cleared Dec 20, 2019
DenMat Orthodontic Aligners
K192470 · NXC
Denmat Holdings, LLC
Dental · 102d
Cleared CT Dec 20, 2019
RHIN1 Stylus
K192471 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 101d
Cleared Dec 20, 2019
Dannik Titanium Ligation Clip
K192711 · FZP
Dannik
General & Plastic Surgery · 84d
Cleared Dec 20, 2019
Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
K192718 · MAX
Pioneer Surgical Technology, Inc....
Orthopedic · 84d
Cleared Dec 20, 2019
Soli-Lite LG4 Galileo
K192755 · GEX
Silhouet-Tone Corporation
General & Plastic Surgery · 81d
Cleared CT Dec 20, 2019
Indigo Aspiration System
K192833 · QEW
Penumbra, Inc.
Cardiovascular · 79d
Cleared Dec 20, 2019
SX-One MicroKnife
K192873 · LXH
Sonex Health, Inc.
Orthopedic · 73d
Cleared Dec 20, 2019
Litho Evo
K192990 · GEX
Quanta System Spa
General & Plastic Surgery · 56d
Cleared Dec 20, 2019
Surgical Direct Hand-held Laparoscopic Instruments
K193018 · GEI
Surgical Direct, Inc.
General & Plastic Surgery · 52d
Cleared Dec 20, 2019
MRopen EVO
K193116 · LNH
Asg Superconductors S.P.A.
Radiology · 38d
Cleared Dec 20, 2019
Ziehm Vision FD
K193230 · OWB
Ziehm Imaging GmbH
Radiology · 25d
Cleared Dec 20, 2019
Telepack +
K193235 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 25d
Cleared Dec 20, 2019
Nexus DR Digital X-Ray Imaging System (with vSharp)
K193238 · MQB
Varex Imaging Corporation
Radiology · 25d
Cleared Dec 20, 2019
UroLift System (UL400)
K193269 · PEW
Neotract, Inc.
Gastroenterology & Urology · 24d
Cleared Dec 20, 2019
Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
K193292 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 23d
Cleared Dec 19, 2019
Krystal Klear Aligners
K182388 · NXC
Shatkin F.I.R.S.T., LLC
Dental · 471d
Cleared Dec 19, 2019
uMC 560i
K183144 · OWB
Shanghai United Imaging Healthcare...
Radiology · 401d
Cleared Dec 19, 2019
DentiqAir
K183676 · LLZ
3D Industrial Imaging Co., Ltd.
Radiology · 356d
Cleared CT Dec 19, 2019
The RHEA Vital Sign Vigilance System
K190775 · BZQ
Shenzhen Fiber Medical Technology Co....
Anesthesiology · 268d
Cleared Dec 19, 2019
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
K190829 · FBK
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 262d
Cleared Dec 19, 2019
Spinal Elements Navigated Instruments
K190881 · OLO
Spinal Elements, Inc.
Orthopedic · 259d
Cleared Dec 19, 2019
EZER, Portable X-ray System
K190935 · EHD
Livermoretech, Inc.
Radiology · 253d