21 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 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