23 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TASK FORCE MONITOR 3040
FDA 510(k)
FDA Class 2
·Cardiovascular
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557938·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557914·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557921·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557969·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557976·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557945·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140030·Cap Starter, T30, Split Tip, Quarter Square
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01406N0·Cervical Rasp, 15 x 12, 6mm, 0 Degree, No Taper
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033561485·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0140030·Counter Torque, Tower Tab
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557952·
COUCH FOR TOTAL BODY RADIATION
FDA 510(k)
FDA Class 2
·Radiology
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 19, 2018
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·March 7, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 10, 2011
INFUSOR PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE, PTE LTD.·Product code FRN·March 13, 2008
syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LLZ·January 12, 2009