15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·Product code KWP·November 2, 2021
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·Product code KWP·November 2, 2021
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·Product code KWP·November 2, 2021
UNICORN MODEL SYS0630
FDA 510(k)
FDA Class 2
·Radiology
PRESSURE ACTIVATED CHECK VALVE
FDA 510(k)
FDA Class 2
·General Hospital
TEXIUM
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FMF·March 19, 2026
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·April 3, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·Product code FKX·March 28, 2011
GLUCOMETER ELITE 4 DATE
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008
Peel-Away
FDA UDI
COOK INCORPORATED·00827002272378·Peel-Away, Introducer Set
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