12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
FDA 510(k)
FDA Class 2
·Immunology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496072393·BE YOU STEP-UP, SIZE M, BLU TONIC, OPAQUE MICRO...
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TINA-QUANT TRANSFERRIN VER.2
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·October 14, 2019
RENAL UROLOGY STENT K072293
FDA Adverse Event
Other
·FOSSA MEDICAL INC·Product code FAD·April 10, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
C-QUR V-PATCH
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code FTL·April 19, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 8, 2011
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010
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