Search FDA 510(k) Database

6,980 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18433–18456 of 174,061
Cleared Apr 27, 2020
Panther Stereotactic
K193459 · MUJ
Prowess, Inc.
Radiology · 133d
Cleared Apr 27, 2020
WOLF Thrombectomy V System
K200101 · QEW
Devoro Medical, Inc.
Cardiovascular · 101d
Cleared Apr 27, 2020
Oxi-W System
K200141 · MWI
Ld Technology, LLC
Anesthesiology · 97d
Cleared Apr 27, 2020
Agape Warming Personal Lubricant
K200208 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 90d
Cleared Apr 27, 2020
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
K200254 · HKI
Optina Diagnostics
Ophthalmic · 84d
Cleared Apr 27, 2020
binx io CT/NG Assay and binx io CT/NG System
K200533 · QEP
Binx Health, Inc.
Microbiology · 56d
Cleared Apr 27, 2020
Capnostream 35 Portable Respiratory Monitor
K200594 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 52d
Cleared Apr 27, 2020
Percutaneous Introducer
K200624 · BSO
Epimed International, Inc.
Anesthesiology · 48d
Cleared Apr 26, 2020
MECTA Sigma
K192834 · QGH
Mecta Corporation
Neurology · 207d
Cleared Apr 26, 2020
ControlRad Sterile Cover
K200238 · KKX
Controlrad, Inc.
General Hospital · 86d
Cleared Apr 25, 2020
i-ED COIL
K192068 · HCG
Kaneka Pharma America, LLC
Neurology · 268d
Cleared Apr 25, 2020
Gatekeeper Balloon Catheter
K192786 · MJN
Arch Catheter, LLC
Cardiovascular · 208d
Cleared Apr 25, 2020
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
K200007 · LZO
Microport Orthopedics, Inc.
Orthopedic · 114d
Cleared Apr 25, 2020
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K200581 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 51d
Cleared Apr 24, 2020
Zircos-Com
K190139 · EBF
Bioden Co., Ltd.
Dental · 451d
Cleared Apr 24, 2020
Maxxi Position Sensor
K191492 · GWQ
Neurovirtual USA, Inc.
Neurology · 324d
Cleared Apr 24, 2020
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K192017 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 270d
Cleared Apr 24, 2020
PGDx elio tissue complete
K192063 · PZM
Personal Genome Diagnostics
Pathology · 267d
Cleared Apr 24, 2020
Custodiol HTK Solution
K192408 · KDL
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 233d
Cleared Apr 24, 2020
MT One
K192856 · GEX
M&T S.R.L.
General & Plastic Surgery · 203d
Cleared Apr 24, 2020
GSI Audera Pro
K193033 · GWJ
Grason Stadler
Neurology · 176d
Cleared Apr 24, 2020
SPIRA-C Integrated Fixation System
K193153 · OVE
Camber Spine Technologies
Orthopedic · 163d
Cleared Apr 24, 2020
SeaSpine Reef TH System
K193636 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 119d
Cleared Apr 24, 2020
O-arm O2 Imaging System
K200074 · OWB
Medtronic, Inc.
Radiology · 101d