8 results
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34ms
·
Sources: EU EUDAMED, US FDA
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC
FDA 510(k)
FDA Class 1
·Dental
Dakewe
FDA UDI
Shenzhen Dakewe Bio-engineering Co., Ltd·06973471960590·1 mL of Inactivated Transport Medium in screw-c...
ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)
FDA 510(k)
FDA Class 2
·Orthopedic
SnapShot Freeze 2
FDA 510(k)
FDA Class 2
·Radiology
MAXPLUS EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·June 27, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·February 28, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011
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