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

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MEDONIC M SERIES

FDA 510(k)
FDA Class 2 ·Hematology

PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB

FDA 510(k)
FDA Class 2 ·Anesthesiology

CHEMWELL, ALSO KNOWN AS PROJECT 2900

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BD ECLIPSE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·September 13, 2023

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 29, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 10, 2011

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FDA Adverse Event
Malfunction ·DATASCOPE CORPORATION·Product code DSP·July 11, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 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