8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
REGENCY TUBE
FDA 510(k)
FDA Class 1
·Dental
SeaSpine Spacer System - Redondo™
FDA UDI
Seaspine Orthopedics Corporation·10889981045364·Trial, 30mm x 24mm x 18mm, 10 Deg Lordotic
FLEXIBLE EXTENDER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·January 30, 2013
EON 16-CHANNEL IPG
FDA Adverse Event
Injury
·SJM NEUROMODULATION DIV.·Product code LGW·December 14, 2010
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 15, 2014
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