BEUDAMED
    19 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA × Status: Open, Classified × Clear all

    XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DPS·December 8, 2023

    API JAMES 2AMP, CATALOG 70542

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    API NIT1 NIT2 REAGENTS, CATALOG 70442

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    API VP1 VP2 REAGENTS, CATALOG 70422

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    API 20 E 25 STRIPS, CATALOG 20100

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JSS·November 9, 2022

    API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JWX·November 9, 2022

    API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JXB·November 9, 2022

    Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code EPY·February 23, 2024

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code EPY·December 3, 2024

    DRX Revolution Mobile X-Ray System

    FDA Recall
    Open, Classified ·Carestream Health, Inc.·Product code IZL·October 2, 2023

    The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.

    FDA Recall
    Open, Classified ·Uvlizer c/o RAIS INTERNATIONAL LLC·Product code RHP·March 6, 2026

    The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.

    FDA Recall
    Open, Classified ·Uvlizer c/o RAIS INTERNATIONAL LLC·Product code RHP·March 6, 2026

    Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025

    Heraeus, PALAMIX uno. Material Number: 66057893.

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code JDZ·March 25, 2026

    Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025

    Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025

    Heraeus, PALAMIX duo. Material Number: 66057897.

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code JDZ·March 25, 2026

    Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025