15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUART ARTERIAL FILTER WITH SOFTLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
TruForm
FDA UDI
Rmo, Inc.·00885797099938·R&L MAX MOLAR 214 BDS W/O LUGS
SYNTHES ANTEROLATERAL CALCANEAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MACROPRO GEL
FDA 510(k)
FDA Unclassified
·Unknown
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 16, 2024
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUAD-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VEMO 7000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
THERMAGE TIP
FDA Adverse Event
Malfunction
·SOLTA MEDICAL·Product code GEI·November 16, 2018
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·May 2, 2013
POWER DRIVE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEY·September 15, 2014
ADD-ON BURETTE
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·April 19, 2011
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·November 8, 2015
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024