81 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Breethe, Inc.
FDA registration
Breethe, Inc.·4 products·🇺🇸 United States
OXY-1 System
FDA UDI
Breethe, Inc.·10860001797968·Console Intake Filter, 5pk
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00860001797985·OXY-1 US Power Cord 3M Qty 1
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00860001797909·OXY-1 System
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00860001797916·Abiomed Breethe OXY-1 PLU Disposable
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00813502012354·OXY-1 Condensate Tray Qty 5
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·10860001797920·Condensation Tray Pouch Assembly
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00813502012361·OXY-1 Console Intake Filter Qty 5
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00860001797947·Pump Driver Service Replacement Kit
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00813502013184·TUBING INSULATOR KIT
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00860001797954·E-Drive Assembly
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00813502013245·Tubing, Translucent Green, 1/4" x 3/8"
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00860001797930·Assy, Console
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
MED-PLASTICS INTL., INC. BREATHING FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
LIFE2000 VENTILATOR PACKAGED
FDA Adverse Event
Injury
·BREATHE TECHNOLOGIES, INC.·Product code CBK·October 30, 2020
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·January 22, 2025
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
FDA Enforcement
Class III
·Terminated·Acon Laboratories, Inc.·August 5, 2015
Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
FDA Recall
Terminated
·Sakar International, Inc.·Product code DJZ·November 30, 2007