11 results
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19ms
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Sources: EU EUDAMED, US FDA
AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Armada
FDA UDI
Nuvasive, Inc.·00887517235220·Armada Ti 3CO Impactor, 15mm Cervical
Prefix Fixator
FDA UDI
ORTHOFIX SRL·18033509855955·PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SC...
Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC Cervical Fusion System, Capstone Spinal System, Capstone PTC Spinal System, Capstone Control Spinal System, Capstone Control PTC Spinal System, Clydesdale Spinal System, Clydesdale PTC Spinal System, Cornerstone PSR Cervical Fusion System, Crescent Spinal System, Crescent Spinal System Titanium, Divergence Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L Anterior/Oblique Lumbar Fus
FDA 510(k)
FDA Class 2
·Orthopedic
TENS 4100
FDA 510(k)
FDA Class 2
·Neurology
SYSMEX CA-1500 ANALYZER
FDA Adverse Event
Injury
·SYSMEX CORP·Product code GKP·March 4, 2013
MAXIMO II VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024