12 results
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25ms
·
Sources: EU EUDAMED, US FDA
AII-PRO 100 PLUS AND ALL-PRO 200
FDA 510(k)
FDA Class 2
·Radiology
Monolith
FDA UDI
Nuvasive, Inc.·00887517677273·Monolith Core, Ø14x35mm
Edge™ Diamond EC014M End Cutting
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172007320·Diamond dental bur, reusable
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
FDA 510(k)
FDA Class 2
·Neurology
DIGITAL RADIOGRAPHY MODEL CXDI-55G
FDA 510(k)
FDA Class 2
·Radiology
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·March 6, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
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