11 results
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20ms
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Sources: EU EUDAMED, US FDA
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496062264·SCOTTISH KNEE-HIGH 100 UNISEX, SIZE XXL, BLU NA...
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
FDA 510(k)
FDA Class 2
·Cardiovascular
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ADVIA CENTAUR XP HCV (AHCV)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZO·December 7, 2016
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 4, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY·Product code GEX·April 12, 2011
PRECISION LINK
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·June 17, 2008
Centricity PACS RA1000
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
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