13 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CELL-DYN EMERALD SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
CELL-DYN EMERALD CLEANER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·April 20, 2016
ARTHREX BIO-POST AND WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
QIVA
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 18, 2019
Cook
FDA UDI
COOK INCORPORATED·00827002135772·Central Venous Pressure Monitoring Set
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·November 4, 2015
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·April 29, 2013
ACTIVA PC
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·April 20, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·July 23, 2008
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·November 17, 2017
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LIT·May 23, 2016
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