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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·July 8, 2020
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·July 8, 2020
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·January 6, 2021
Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·January 6, 2021
REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·January 6, 2021
REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·January 6, 2021
REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·January 6, 2021
REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·January 6, 2021
MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i (integrated) and MX 15 HDi. Long range surveillance, target designation.
FDA Recall
Terminated
·Wescam Inc
649 North Service Road West
Burlington Canada Ontario·Product code RET·August 1, 2009
IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X.
FDA Recall
Terminated
·Intelerad Medical Systems Inc. 460 Ste-Catherine West Suite 210 Montreal Canada·Product code LLZ·October 27, 2008
IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
FDA Recall
Terminated
·Intelerad Medical Systems Inc. 460 Ste-Catherine West Suite 210 Montreal Canada·Product code LLZ·October 27, 2008