12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VAPRO INTERMITTENT CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304425880·
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
V.A.C. GRANUFOAM SILVER DRESSING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONCO TRAC MODEL 1, 2, 4
FDA 510(k)
FDA Class 2
·Radiology
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929035184·Corpectomy, 14Dx16Wx42H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065228·Corpectomy, 14Dx16Wx42H 0°
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 24, 2016