8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
BILE ESCULIN AGAR
FDA 510(k)
FDA Class 1
·Microbiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517362469·CoRoent® SI Screw, 4.5x14mm Rescue
Alliance Glenoid
FDA 510(k)
FDA Class 2
·Orthopedic
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FIRSTPASS SUTURE PASSER
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GAT·January 21, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 15, 2012
OCTRODE 8 PERCUTANEOUS LEAD
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 4, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024