9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ANTICARDIOLIPIN ANTIBODY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Brigade
FDA UDI
Nuvasive, Inc.·00887517963420·Brigade Lateral Trial, 11x38x28mm 20°
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PRESTIGE 24I; BIOLIS 24I; MGC 240
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODEL NOT SPECIFIED
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014
ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·November 19, 2010
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·January 9, 2013
PST 500
FDA Adverse Event
Malfunction
·BAXTER MEDICAL SYSTEMS GMBH + CO. KG·Product code GDC·July 8, 2024
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