7 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 22, 2025
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 9, 2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 9, 2024
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·November 6, 2024
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·January 24, 2024
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·January 24, 2024
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·January 29, 2025