10 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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AMSCO WARMING CABINET
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO HANDMASTER
FDA 510(k)
FDA Class 2
·Neurology
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 16, 2019
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 24, 2019
SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 26, 2019
ACUITY STEERABLE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NVY·May 3, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 5, 2011
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 31, 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