12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
XBO1-824-18/19/20 BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES
FDA 510(k)
FDA Class 2
·Cardiovascular
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·June 8, 2006
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code JPA·June 8, 2006
SPACEMAKER BLUNT TIP TROCAR 10MM
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC·Product code GCJ·March 6, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 28, 2011
ENDO GIA ROTICULATOR 45-3.5 SULU
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GAG·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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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