18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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R120 MODULAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012055·Zirlux 16+ B3 95X18
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327937·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327906·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327913·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327951·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327920·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327944·
MINIMED MIO ADVANCE
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·July 18, 2025
CRYOCARE SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVL HINGE KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MINIMED MIO ADVANCE
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 8, 2025
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·February 2, 2016
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·March 19, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 9, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC·Product code JAA·March 11, 2008
MODULAR FEMORAL STEM PRESS-FIT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 10, 2020
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