12 results
·
17ms
·
Sources: EU EUDAMED, US FDA
GARELICK COMMODE
FDA 510(k)
FDA Class 1
·Physical Medicine
FacetLINK MI
FDA UDI
LINKSPINE, INC.·00817329024514·Trocar Stylet
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7402802511·Rampart-O
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7403802511·Asm, Rampart-O
Rampart-O
FDA UDI
SPINEOLOGY INC.·M9403802511·Asm, Rampart-O
FETALTROL
FDA 510(k)
FDA Class 2
·Hematology
MEDIGARD BLOOD COLLECTION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
MERLIN PROGRAMMER
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code KRG·May 9, 2014
PLATE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·October 24, 2012
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·August 17, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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