11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
RAD-57 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496053477·LONG, SIZE XL, BLU NAVY, MICRO-MASSAGING LEGGIN...
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 12, 2021
BIOLOY
FDA 510(k)
FDA Class 2
·Dental
TOCO LITE, MODEL TD-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 6, 2025
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 11, 2013
TOTAL CARE SPORT BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 17, 2011
TARGET DEVICE 300X160MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·May 28, 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