9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AQUADYNE
FDA 510(k)
FDA Class 2
·Physical Medicine
Intuitive Workflow Tools
FDA UDI
Barco NV·05415334002050·accessories for image enhancement in diagnostic...
EVERSTICK POST
FDA 510(k)
FDA Class 1
·Dental
EXPANDABLE LUMBAR INTERBODY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HU-FRIEDY PERMA SHARP SUTURES
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAR·May 26, 2010
RENAL - DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 16, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 12, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020