12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Dental
CAPSTONE® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994290892·SPACER 2991436 CAPSTONE PEEK 14X36
Monolith
FDA UDI
Nuvasive, Inc.·00887517698025·Monolith Core, Ø14x36mm
Saalio
FDA 510(k)
FDA Class 2
·Physical Medicine
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
FDA 510(k)
FDA Class 2
·Radiology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 6, 2013
ATTAIN PERFORMA
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·August 8, 2014
LINEAGE(R) A-CLASS(R) LINER
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·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