19 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XIA STAINLESS STEEL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
t:slim X2 Insulin Pump with Control-IQ Technology
FDA UDI
Tandem Diabetes Care, Inc.·00389152287010·
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 2, 2026
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033447109·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033447116·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361012047·PedFuse Respond, SLD, 7.0mm x 70mm
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033447093·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033447147·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033447130·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033447123·
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ILET BIONIC PANCREAS
FDA Adverse Event
Malfunction
·BETA BIONICS INC.·Product code QFG·March 12, 2026
AXIOS STENT AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code PCU·June 12, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT·Product code CBK·March 1, 2013
TRANSPORT SERIES
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 3, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 12, 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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014