9 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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SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
FDA 510(k)
FDA Class 2
·General Hospital
SCI-PHARM POST SECURE
FDA 510(k)
FDA Class 2
·Dental
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·October 9, 2018
IBP ELB INT. ULNA LRG RGT LNG STM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·June 24, 2016
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 9, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 28, 2011
SELUTE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
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