9 results
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29ms
·
Sources: EU EUDAMED, US FDA
OMNIFIT DISTAL STEM CEMENT SPACERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GC Initial™
FDA UDI
Gc America Inc.·15400556709587·GC Initial™ IQ/Effect Ingot Bleach AO-M, 4 pcs....
GC Initial™
FDA UDI
Gc America Inc.·J0228725281·GC Initial™ IQ/Effect Ingot Bleach AO-M, 4 pcs....
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
PFIZONIC 150 ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
LOCKING BLUNT CANNULA 11 GAUGE
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·May 21, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·October 12, 2010
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 13, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024