15 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
LTV 1200 VENTILATOR
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL, INC·Product code CBK·November 13, 2023
LTV 1200 VENTILATOR
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL, INC·Product code CBK·December 13, 2023
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·December 20, 2017
MODIFICATION TO XIA SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VIEW READING STATION
FDA 510(k)
FDA Class 2
·Radiology
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZL·September 6, 2017
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 29, 2013
QUICK FLEX LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·May 10, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQL·July 28, 2008
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
VERCISE? CARTESIA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·February 20, 2026
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