5 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Tandem Mobi Insulin Pump with Interoperable Technology
FDA Enforcement
Class I
·Ongoing·Tandem Diabetes Care, Inc.·April 23, 2025
t:slim X2 Insulin Pump with Interoperable Technology
FDA Enforcement
Class I
·Ongoing·Tandem Diabetes Care, Inc.·April 23, 2025
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 12, 2023
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 12, 2023
Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X15B, RU2200X15B
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 12, 2023