8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CERALAS D LASER SYSTEM, MODEL # CERALAS D15
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983058·posteriors; shade B3; size L; upper jaw
IBA PROTON THERAPY SYSTEM - PROTEUS 235
FDA 510(k)
FDA Class 2
·Radiology
Arm-type Electronic Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 28, 2013
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 4, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 6, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024