14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHASEAL PROTECTOR P14, P21, P28 AND P50
FDA 510(k)
FDA Class 2
·General Hospital
Amara View
FDA UDI
Respironics, Inc.·00606959009240·Amara View Mask without Headgear, USA, Large
LEONE SPA
FDA UDI
LEONE SPA·08033707065685·INTRAORAL ELASTICS 4,5 oz 1/8" brown
Phonak
FDA UDI
Phonak AG·07612847818491·Phonak Ambra microP (light blue)
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 18, 2023
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
FDA 510(k)
FDA Class 3
·Cardiovascular
ROD TO ROD CROSS BRACES
FDA 510(k)
FDA Class 2
·Orthopedic
VKMO 78000 3 QUADROX-I HMO 70000+VHK7000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015
VKMO 78000 #QUADROX-I HMO 70000+VHK7000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016
0.8% SURGISCREEN FOR GEL
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·May 2, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 19, 2011