10 results
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50ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
FDA Enforcement
Class II
·Terminated·Compass Health Brands·June 17, 2015
MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
FDA Enforcement
Class II
·Terminated·Compass Health Brands (Corporate Office)·May 22, 2019
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
FDA Enforcement
Class II
·Terminated·Compass Health Brands (Corporate Office)·May 22, 2019
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.
FDA Enforcement
Class I
·Terminated·Compass Health Brands (Corporate Office)·August 29, 2018
MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
FDA Enforcement
Class II
·Terminated·Compass Health Brands (Corporate Office)·May 22, 2019
MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
FDA Enforcement
Class II
·Terminated·Compass Health Brands (Corporate Office)·May 22, 2019
MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
FDA Enforcement
Class II
·Terminated·Compass Health Brands (Corporate Office)·May 22, 2019
MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
FDA Enforcement
Class II
·Terminated·Compass Health Brands (Corporate Office)·May 22, 2019
Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080
FDA Enforcement
Class II
·Ongoing·Compass Health Brands (Corporate Office)·January 26, 2022
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
FDA Enforcement
Class II
·Ongoing·Compass Health Brands (Corporate Office)·April 26, 2023