8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ACTIVE VERTICAL CORRECTOR ACTIVE BITE
FDA 510(k)
FDA Class 1
·Dental
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NeoMed NeoConnect Enteral Syringes with ENFit Connector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 2, 2014
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 23, 2012
SYNCHROMED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·September 22, 2010
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
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