12 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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STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
FDA 510(k)
FDA Class 2
·Hematology
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICK-CORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FCG·September 4, 2018
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Malfunction
·COOK, INC.·Product code MIH·March 28, 2013
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 11, 2011
ES GENERATOR - 120 VOLT
FDA Adverse Event
Injury
·COVIDIEN LP (VALLEYLAB)·Product code GEI·June 19, 2008
DIMENSION VISTA®
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·August 28, 2018
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015