12 results · 22ms · Sources: EU EUDAMED, US FDA

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MISER CONTRAST MANAGEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

K083526

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·May 7, 2018

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code CBK·July 20, 2021

PERICSCOPE, MODEL # PERISC1

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

Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013

BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

FDA Adverse Event
LAND AMERICA HEALTH & FITNESS·Product code FNL·April 29, 2013

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 10, 2011

SCREWDRIVER SHAFT SHORT, NON-CANNULATED, 2.5MM HEX

FDA Adverse Event
Other ·ARTHREX, INC.·Product code HXX·July 24, 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