9 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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CARDIQ FUNCTION XPRESS
FDA 510(k)
FDA Class 2
·Radiology
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 23, 2024
SOLOBOND PLUS
FDA 510(k)
FDA Class 2
·Dental
AUTOTOME RX MODEL # 4515, 4516
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERCISE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·September 13, 2024
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 23, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 29, 2011
CURRENT VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 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