9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTOMATIC PERITONEAL DIALYSIS CYCLER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PULSE
FDA UDI
Nuvasive, Inc.·00195377060334·PULSE Cable, 25ft DVI-DVI Male-Male
V-PRO maX 2 Low Temperature Sterilization System
FDA 510(k)
FDA Class 2
·General Hospital
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
FDA 510(k)
FDA Class 2
·Dental
XLD 110V L.A. REF
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 25, 2014
IM NAIL
FDA Adverse Event
Injury
·SIGN FRACTURE CARE INTL·Product code HSB·November 5, 2012
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·September 14, 2010
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
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