9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
FILE TYPE H (HEDSTROEM) ENDODONTIC
FDA 510(k)
FDA Class 1
·Dental
DENTURE ADJUSTMENT KIT
FDA 510(k)
FDA Class 2
·Dental
SmoothCool HR System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3CC 25X5/8 MAGELLAN SAFETY COMBO
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMI·May 1, 2014
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·November 16, 2007
BIPOLAR CUTTING LOOP ELECTRODE - DEVICE #4
FDA Adverse Event
Malfunction
·RICHARD WOLF MEDICAL INSTRUMENTS·Product code KNS·September 3, 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,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015