12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
FDA 510(k)
FDA Class 2
·Anesthesiology
PB560 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 22, 2011
APPLIED ACCESS SEAL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDLINE STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
PB560 VENTILATOR X1
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011
VERSACARE BED
FDA Adverse Event
Injury
·HILL-ROM, INC.·Product code FNL·April 24, 2013
OT VERIO METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 10, 2011
CALAXO - UNKNOWN
FDA Adverse Event
Other
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·July 25, 2008
BD POSIFLUSH¿ SALINE SYRINGE
FDA Adverse Event
Injury
·BECTON DICKINSON, S.A.·Product code NGT·August 15, 2022
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·September 27, 2018
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