7 results
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15ms
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Sources: EU EUDAMED, US FDA
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
FDA Enforcement
Class I
·Ongoing·Ventec Life Systems, Inc.·March 5, 2025
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
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
FDA Enforcement
Class I
·Ongoing·Ventec Life Systems, Inc.·March 6, 2024
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
FDA Enforcement
Class I
·Ongoing·Ventec Life Systems, Inc.·May 13, 2026
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
FDA Enforcement
Class I
·Terminated·Pro-Med Instruments Gmbh·September 26, 2018
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
FDA Enforcement
Class I
·Terminated·Pro-Med Instruments Gmbh·September 26, 2018
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
FDA Enforcement
Class I
·Terminated·Pro-Med Instruments Gmbh·September 26, 2018