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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDPOR OCULAR SCREW AND ACCESSORIES
FDA Adverse Event
Injury
·POREX SURGICAL·Product code MQU·October 15, 2010
Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. The affected model which is the subject of this recall comes with the flat peg.
FDA Recall
Terminated
·Integrated Orbital Implants Inc·Product code MQU·December 20, 2006
Ocular Peg
FDA classification
FDA Class 2
·Ocular Peg
MEQU A/S
FDA registration
MEQU A/S·2 products·🇩🇰 Denmark
°M Warmer System - Power Pack
FDA UDI
Mequ A/S·05745000140039·Rechargeable battery pack for powering the °M W...
°M Warmer System - Power Pack+
FDA UDI
Mequ A/S·05745000140046·Rechargeable battery pack for powering the °M W...
°M Warmer System - Starter Kit+
FDA UDI
Mequ A/S·05745000140022·The °M Warmer System is indicated for use to wa...
°M Warmer System - Starter Kit
FDA UDI
Mequ A/S·05745000140015·The °M Warmer System is indicated for use to wa...
°M Warmer System - Charger
FDA UDI
Mequ A/S·05700002076847·Charger for charging the Power Pack / Power Pac...
°M Warmer System - °M Warmer
FDA UDI
Mequ A/S·05700002076816·Disposable IV Fluid / Blood Warmer unit
AUTO SECTOR MCU
FDA 510(k)AUTO SECTOR MCU
FDA 510(k)
FDA Class 2
·Radiology
Central Archive module
FDA UDI
ORPHEUS MEDICAL LTD·07290017025087·
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749036534·Mercedes thoracic retractor
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749036503·Blades for Mercedes retractor 50 x 65 mm fenest...
Orpheus CAST App
FDA UDI
ORPHEUS MEDICAL LTD·07290017025094·A Windows based desktop widget application that...
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749036510·Blades for Mercedes retractor 75 x 75 mm fenest...
V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU
FDA 510(k)
FDA Class 2
·Neurology
MCU Multi-Cervical Unit
FDA UDI
BTE TECHNOLOGIES, INC.·10850390007427·A rehabilitation device for neck strengthening ...
Main Controller Unit (MCU)
FDA UDI
Meditech International Inc·B271MCU0·