9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HEARTRAIL III GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSMEX UF-50
FDA 510(k)
FDA Class 2
·Hematology
ACCESS ALERT GAUGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
SWIFT-LOCK ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·January 23, 2018
SONOMA CRX
FDA Adverse Event
Injury
·SONOMA ORTHOPEDIC PRODUCTS INC.·Product code HSB·April 30, 2013
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL
FDA Adverse Event
Injury
·ONSET MEDICAL CORPORATION·Product code DYB·September 4, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 3, 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