20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sensis
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768475·GENUMEDI PSS GREEN III
Orthopedic Salvage System (OSS)
FDA UDI
Biomet Orthopedics, LLC·00880304240094·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100141·KRATZ-BARRAQUER HEAVY WIRE SPECULUM
TANDEMHEART PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
QUANTIA IGE
FDA 510(k)
FDA Class 2
·Immunology
OSS RS 14MM LS TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·August 24, 2023
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
VEST, MODEL 105
FDA Adverse Event
Injury
·HILL-ROM SERVICES PRIVATE LIMITED·Product code BYI·June 23, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
CAPIOX RX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·May 26, 2023
CAPIOX RX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 20, 2018
OSS 7CM SEG ELLIPT FEMORAL RT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 18, 2019
OSS TIBIAL POLY BEARING 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 18, 2019
CAPIOX RX OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024
OSS RS AXLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·August 3, 2023
OSS POLY LOCK PIN
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·August 3, 2023
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·January 31, 2024
CAPIOX®RX
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 9, 2024
CAPIOX RX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 5, 2018