17 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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CEI Cutting Edge Instruments (PTC-57C)
FDA Enforcement
Class II
·Ongoing·Coltene Whaledent Inc·November 25, 2020
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
FDA Enforcement
Class II
·Ongoing·New Medical Technologies Gmbh·February 12, 2025
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
FDA Enforcement
Class II
·Ongoing·New Medical Technologies Gmbh·February 12, 2025
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·September 7, 2022
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·June 29, 2022
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·June 21, 2023
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
FDA Enforcement
Class II
·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 22, 2025
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
FDA Enforcement
Class II
·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 2, 2024
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
FDA Enforcement
Class II
·Ongoing·Fisher & Paykel Healthcare, Ltd.·May 22, 2024
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025