11 results
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24ms
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Sources: EU EUDAMED, US FDA
GORE-TEX FACIAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·June 23, 2025
TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464
FDA 510(k)
FDA Class 2
·Radiology
ORTHOVIS PREOPERATIVE PLAN
FDA 510(k)
FDA Class 2
·Radiology
EYE STRETCHER CHAIR
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 14, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 2014
RESIDENT BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 21, 2012
T2 - NAIL HANDLE
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015