7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
FDA Enforcement
Class II
·Ongoing·Invacare Corporation·March 13, 2024
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
FDA Enforcement
Class II
·Ongoing·Invacare Corporation·June 1, 2022
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
FDA Enforcement
Class III
·Ongoing·Invacare Corporation·July 20, 2022
Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG
FDA Enforcement
Class II
·Ongoing·Invacare Corporation·January 12, 2022
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
FDA Enforcement
Class II
·Ongoing·Invacare Corporation·August 30, 2023
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C
FDA Enforcement
Class II
·Ongoing·Invacare Corporation·January 12, 2022
Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP
FDA Enforcement
Class II
·Ongoing·Invacare Corporation·January 12, 2022