39 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017
CoRoent
FDA UDI
Nuvasive, Inc.·00887517563705·CoRoent Ant TLIF PEEK, 10x13x34mm 0°
MOLT PERIOSTEAL ELEVATOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896093928·MOLT PERIOSTEAL ELEVATOR DOUBLE ENDED TIPS #EX-1
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197265478·Martin Pelvimeter
34 cm,...
OBC-149 BREAST ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
RT-PLUS KNEE ADDITIONAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN SOLITAIRE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·March 1, 2021
UNKNOWN SOLITAIRE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·March 1, 2021
UNKNOWN SOLITAIRE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·March 1, 2021
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALUE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 21, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 9, 2012
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 9, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·September 19, 2014
ATRIUM HERNIA REPAIR MESH
FDA Adverse Event
Injury
·ATRIUM·Product code FTL·May 20, 2011
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 14, 2012