9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
FDA 510(k)
FDA Class 2
·Radiology
Armada
FDA UDI
Nuvasive, Inc.·00887517234438·Armada Ti 3CO Impactor, 35mm Lumbar
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122918·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 125mm
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRESIDIO PACS
FDA 510(k)
FDA Class 2
·Radiology
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·March 7, 2013
SIGMA 300 S
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022