17 results · 20ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO SOLAR GI

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

INTROCAN SAFETY IV CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

E500 VENTILATOR SYSTEM

FDA Adverse Event
Injury ·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016

DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL·Product code OJX·August 12, 2023

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC·Product code DTB·August 12, 2023

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC·Product code DTB·August 11, 2023

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 27, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

MEDTRONIC-SOLETRA NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC·Product code MHY·July 7, 2008

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026

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