12 results · 29ms · Sources: EU EUDAMED, US FDA

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PRE-POWDERED VINYL EXAM GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

BD¿ LUER SLIP TIP SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 29, 2022

MAGELLAN VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

AUTOSOFT 90

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·November 18, 2024

AMI

FDA Adverse Event
Other ·AIRWAY MANAGEMENT INC.·Product code LRK·July 10, 2013

GREENLIGHT MOXY FIBER OPTIC

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·March 6, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011

INSIGNIA ENTRA

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

PKG, BABCOCK FORCEPS, P/N 0250080321. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

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