19 results · 29ms · Sources: EU EUDAMED, 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