10 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3
FDA 510(k)
FDA Class 2
·Anesthesiology
OneTouch Ultra Plus Flex
FDA UDI
LifeScan Europe GmbH·00353885012621·OneTouch Ultra Plus Flex™ Blood Glucose Monitor...
MININEPH HUMAN B2-MICROGLOBULIN KIT
FDA 510(k)
FDA Class 2
·Immunology
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JSM·April 25, 2018
ULTRASONIC IMAGING CATHETER - CORONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·March 27, 2013
LEICA M525 F40
FDA Adverse Event
Malfunction
·LEICA MICROSYSTEMS (SCHWEIZ) AG·Product code EPT·March 10, 2011
TWINFIX ANCHOR
FDA Adverse Event
Malfunction
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code MBI·March 27, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018