8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BI-3M NEEDLE-FREE INJECTOR SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PCCR DIGITAL IMAGING DEVICE
FDA 510(k)
FDA Class 2
·Radiology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 5, 2013
15 CUDA BENDABLE TO 30
FDA Adverse Event
Injury
·CONMED CORP.·Product code HRX·September 15, 2014
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·May 3, 2011
C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 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