Search FDA 510(k) Database

7,039 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19465–19488 of 174,061
Cleared 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 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
Cleared Dec 19, 2019
ZOLL Arrhythmia Management Sysyem
K190939 · MHX
Zoll Manufacturing Corporation
Cardiovascular · 253d
Cleared Dec 19, 2019
Hereaeus Poseidon Microcatheter
K191305 · KRA
Heraeus Medical Components, LLC
Cardiovascular · 219d
Cleared Dec 19, 2019
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
K191314 · HKY
Chongqing Sunkingdom Medical...
Ophthalmic · 218d
Cleared Dec 19, 2019
TK Sterile Hypodermic Needle
K191643 · FMI
Anhui Tiankang Medical Technology...
General Hospital · 183d
Cleared Dec 19, 2019
4CIS Marlin PEEK ACIF Cage
K192044 · ODP
Solco Biomedical Co., Ltd.
Orthopedic · 141d
Cleared Dec 19, 2019
Aveta Disposable Hysteroscope
K192100 · HIH
Meditrina, Inc.
Obstetrics & Gynecology · 136d
Cleared Dec 19, 2019
Neodent Implant System- GM Titanium Base for Bridge
K192229 · NHA
Jjgc Industria E Comercio DE...
Dental · 125d