8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MARZ-175 ARTERIAL BLOOD GAS SYRINGE
FDA 510(k)
FDA Class 1
·Anesthesiology
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
FDA 510(k)
FDA Class 2
·Cardiovascular
TH0R DDII IR LAMP SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LOX·May 27, 2014
5.2MM TI DUAL-OPENING SCREW 30MM THRD LENGTH F/6.0MM RODS
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·November 15, 2012
PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·September 14, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024