21 results · 15ms · Sources: EU EUDAMED, US FDA

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TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code NAW·July 23, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code NAW·July 23, 2021

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 Recall
Open, Classified ·New Standard Device Inc·Product code KTT·December 28, 2020

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

FDA Recall
Open, Classified ·New Standard Device Inc·Product code KTT·July 23, 2019

Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

FDA Recall
Open, Classified ·New Standard Device Inc·Product code HXC·August 14, 2019

Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08

FDA Recall
Open, Classified ·Medivance Inc.·Product code DWJ·June 27, 2024

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

FDA Recall
Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

FDA Recall
Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

FDA Recall
Open, Classified ·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025

Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

FDA Recall
Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·April 2, 2024

Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

FDA Recall
Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·September 18, 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 Recall
Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code QAV·August 7, 2024

Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

FDA Recall
Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

FDA Recall
Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

FDA Recall
Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

FDA Recall
Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;

FDA Recall
Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

FDA Recall
Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

FDA Recall
Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

FDA Recall
Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024