8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAYCELL X-RAY BLOOD IRRADIATOR
FDA 510(k)
FDA Unclassified
·Unknown
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·January 8, 2019
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO·Product code DTB·April 10, 2013
DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCW·May 22, 2008
LAMITRODE S4 SURGICAL LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 5, 2011
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