9 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
FDA Enforcement
Class II
·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
FDA Enforcement
Class II
·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
FDA Enforcement
Class II
·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Recall
Completed
·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code ITX·March 14, 2025
Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4
FDA Recall
Completed
·Cytrellis Biosystems, Inc.·Product code QAI·April 7, 2023
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
FDA Recall
Completed
·Beckman Coulter, Inc.·Product code CDD·February 27, 2025
Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel
FDA Recall
Completed
·International Science & Technology, LP, DBA Diamatrix Ltd.·Product code HNN·February 24, 2022
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.
FDA Recall
Completed
·Avanos Medical, Inc.·Product code GXD·August 1, 2023
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
FDA Recall
Completed
·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024