11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
READY NURSE SYSTEM (RNS) TRACH CARE KIT
FDA 510(k)
FDA Class 1
·Unknown
Laminoplasty
FDA UDI
Seaspine Orthopedics Corporation·10889981096069·6mm Mouth, In-Line Implant Caddy
SMARTPREP2 CENTRIFUGE SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
FDA 510(k)
FDA Class 2
·Microbiology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 20, 2014
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·February 9, 2013
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code MMI·January 7, 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