10 results
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20ms
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Sources: EU EUDAMED, US FDA
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032177·Baltic Denture System BDLoad ↓ Mm7 PLSEum2DFm B...
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
FDA 510(k)
FDA Class 2
·Hematology
VENTVIEW, MODEL 8414095
FDA 510(k)
FDA Class 2
·Anesthesiology
FIRSTPASS MINI STRAIGHT
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code NBH·November 29, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 7, 2013
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 29, 2011
XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code FGE·April 21, 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
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