10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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B. BRAUN BICARBONATE DIALYSATE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NURVO 9000 ENDOCAVITARY COILS
FDA 510(k)
FDA Class 2
·Radiology
SYSMEX R-500
FDA 510(k)
FDA Class 2
·Hematology
STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 30, 2021
11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HSB·April 8, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 6, 2011
VITALITY AVT FAST-CHARGE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
EVAC STATION
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·November 12, 2019
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013