9 results
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17ms
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Sources: EU EUDAMED, US FDA
BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GC Initial™
FDA UDI
Gc America Inc.·15400556702700·GC Initial™ MC Powder Opaque OD3, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228701851·GC Initial™ MC Powder Opaque OD3, 20g
tremoFlo C-100 Airwave Oscillometry System
FDA 510(k)
FDA Class 2
·Anesthesiology
TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK PRIMARY PS CEMENTED FEMUR #4 NARROW RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·May 28, 2014
ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 15, 2010
C-STEM AMT SZ2 HIGH OFFSET
FDA Adverse Event
Injury
·DEPUY SUZHOU·Product code JDI·December 12, 2012
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024