11 results
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37ms
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Sources: EU EUDAMED, US FDA
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLELESS TRANSFER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
RATCHET T-HANDLE 6MM QC
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·April 2, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 21, 2011
PRECISION XTRA/OPTIUM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 18, 2008
LIFEWISE BLOOD PRESSURE MONITOR
FDA Adverse Event
Injury
·RADIOSHACK·Product code DXN·October 20, 2004
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