13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EtchPro Etching Gel
FDA 510(k)
FDA Class 2
·Dental
OsteoMed
FDA UDI
OSTEOMED LLC·00845694043090·1.6mm Extended Pilot Drill, 6mm Stop, J-Latch
Instrument Tray
FDA UDI
Treace Medical Concepts, Inc.·00810111225489·Forefoot Instrument Tray
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450022849·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706046·Hohmann Retractor 9-1/4" (23.1cm), blade 10mm wide
microTargeting™ Electrode
FDA UDI
FHC, INC.·00873263004623·microTargeting(TM) Electrode, differential, tun...
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
FDA 510(k)
FDA Unclassified
·Unknown
SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018
FDA 510(k)
FDA Class 2
·Physical Medicine
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 1, 2013
PALMAZ STENT LARGE ILIACR 30MM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code FGE·May 16, 2013
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014