8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SYSTEM WASHER 100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9362581·SIC Fixation Post "Safe on Four", GH 3.0 mm
TRACET T-6000
FDA 510(k)
FDA Class 2
·Cardiovascular
DLX
FDA 510(k)
FDA Class 2
·Radiology
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·January 30, 2013
SILICONE ADVANCED OPTIC LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·December 14, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·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