13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIRA-FLEX 18 MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DUO PAL 6, ORDER-NO.: 2154
FDA 510(k)
FDA Class 2
·Dental
COOL-TEC ELECTRODES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NQO·October 24, 2007
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·July 30, 2010
TPS BI-DIRECTIONAL FOOTSWITCH
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·April 11, 2013
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·May 27, 2008
EASYTRAK
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 13, 2011
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·December 5, 2023
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·September 12, 2023
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·September 12, 2023
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·September 12, 2023
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