8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001
FDA 510(k)
FDA Class 2
·Cardiovascular
BD SAFETYGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·September 23, 2019
CADHEALTH SYSTEM, MODEL CHP-001
FDA 510(k)
FDA Class 2
·Cardiovascular
DIGIPAN / DPI
FDA 510(k)
FDA Class 2
·Dental
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 11, 2013
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·May 22, 2008
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 13, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012