13 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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NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
Genesys Spine Surgical Light Cable
FDA UDI
Lumitex, Inc.·00812432021221·
BODY GLOVE
FDA UDI
FGX INTERNATIONAL INC.·00193033341513·
BODY GLOVE
FDA UDI
FGX INTERNATIONAL INC.·00193033341506·
BODY GLOVE
FDA UDI
FGX INTERNATIONAL INC.·00193033341520·
KSEA PERCUTANEOUS FORAMINOSCOPY SET
FDA 510(k)
FDA Class 2
·Orthopedic
LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
FDA 510(k)
FDA Class 3
·Cardiovascular
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 9, 2025
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 9, 2025
TRINKLE QUICK-COUPL DRILLING SPEED MODIF
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·March 19, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 9, 2011
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, DR·Product code DYG·March 10, 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