12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PANTHER REALART, MODEL 4.7
FDA 510(k)
FDA Class 2
·Radiology
SIMPLICITY CLASSIC WING QD INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
JEWEL CAST PLUS
FDA 510(k)
FDA Class 2
·Dental
AVIATOR ASSY TWO LEVEL PLATE SIZE 28
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWQ·October 17, 2016
DIDECO COMPACTFLO EVO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·April 29, 2013
CRE(TM) BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KOG·May 10, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·July 29, 2008
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014
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