8 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
XPI ANGLED ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
TRUMATCH PERSONALIZED SOLUTIONS
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2017
MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DRA·October 21, 2014
RAPIDPOINT 405
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code GKR·June 18, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 28, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024