11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARRIER* EXTRA PROTECTION PLUS FACE MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756363655·KYPHOPLASTY PREP TRAY
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756104203·HAND SPLINT
Bio-Medicus Insertion Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
JAX GRANULES BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 4, 2017
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION·Product code HAW·November 19, 2010
4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 14MM
FDA Adverse Event
Death
·SYNTHES USA·Product code KWQ·July 2, 2014
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024