12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAGNETOM ESSENZA WITH SYNGO MR D14
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776297800·Beasley-Babcock Tissue Forcep, 6x7 teeth, 5"
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925012448·GUILFORD DUCKBILL ELEVATOR, SM
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180685·Integra® Jarit® Beasley-Babcock Forceps, Tissue...
SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 24, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 30, 2014
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·June 13, 2011
BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 21, 2022
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 28, 2025
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015