13 results
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19ms
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Sources: EU EUDAMED, US FDA
RITA CLIPS FOR INFUSION PUMPS
FDA 510(k)
FDA Class 2
·General Hospital
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
FDA 510(k)
FDA Class 2
·Radiology
VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
BD ULTRA FINE¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·December 18, 2018
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGZ·April 2, 2013
EON C 16-CHANNEL IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 22, 2011
CLINICAL INFORMATION CENTER
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code DRT·April 17, 2008
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
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