8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EZY-TRAVEL WRISTBAND
FDA 510(k)
FDA Unclassified
·Unknown
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027
FDA 510(k)
FDA Class 2
·Cardiovascular
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MELODY TRANSCATHER PULMONARY
FDA Adverse Event
Injury
·HEART VALVES SANTA ANA·Product code NPV·April 8, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·March 29, 2011
VITALITY AVT
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 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