11 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROCARE
FDA UDI
DJO, LLC·00888912038515·PERSONAL LIMB HOLDER, 40 PR
PWD Platform Wound Dressing 3 x 5 Oblong
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OPT BLADELESS 12X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·March 6, 2013
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·February 15, 2011
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