8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTOPACK NON-EUGENOL PERIODONTAL DRESSING
FDA 510(k)
FDA Class 2
·Dental
MITEK BIOCRYL INTERFERENCE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALTRX +4 NEUT 36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 14, 2013
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC EUROPE SARL·Product code LGW·November 12, 2010
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021