10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SUPER SHEATH INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
TRIUMPH VTX WITH LIFEVALVE CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PEN NDL 32G 4MM PRO 90CT US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·October 22, 2024
PEN NDL 32G 4MM PRO 90CT US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·July 23, 2024
PEN NDL 32G 4MM PRO 90CT US
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·April 9, 2024
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
CUSTOM PAK
FDA Adverse Event
Injury
·ALCON - HOUSTON·Product code KYG·April 8, 2011
AUTOCAT 2 WAVE JAPANESE
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DSP·May 22, 2008
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