13 results
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38ms
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Sources: EU EUDAMED, US FDA
TI FENESTRATED PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
FDA 510(k)
FDA Class 2
·Ophthalmic
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·September 14, 2017
CONNECTA PLUS3 10CM WHITE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·September 9, 2019
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·April 2, 2013
KANGAROO EPUMP - NEW
FDA Adverse Event
Malfunction
·COVIDIEN·Product code LZH·March 21, 2011
SHOULDER SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSD·April 18, 2008
BD DISCARDIT¿ II - 2-PIECE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 13, 2023
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016