19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GE DELTA SOFTWARE OPTION FOR MRI
FDA 510(k)
FDA Class 2
·Radiology
Verteloc Lumbar Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215129309·
Arlington PLIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215026301·
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 16, 2006
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
FDA 510(k)
FDA Class 2
·Cardiovascular
MINI SHOPPER
FDA 510(k)
FDA Class 2
·Physical Medicine
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 26, 2006
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 26, 2006
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 27, 2006
RAPIDPOINT 405
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS,·Product code CHL·March 25, 2013
NC QUANTUM APEX BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 28, 2011
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 17, 2008
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 1, 2025
BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM)
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 3, 2020
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013