10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ESL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED FEMORAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 19, 2024
FEMOSTOP
FDA Adverse Event
Malfunction
·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 21, 2003
SELUTE PICOTIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·May 3, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 2, 2011
FEMOSTOP
FDA Adverse Event
Injury
·RADI MEDICAL SYSTEMS·Product code DXC·August 20, 2003
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