BEUDAMED
    5,475 results · 17ms · Sources: EU EUDAMED, US FDA

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    Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Enforcement
    Class I ·Ongoing·WHILL, INC.·May 6, 2026

    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    Yeastone Broth, 11ML, 10/BOX YY3462

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·April 22, 2026

    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

    FDA Enforcement
    Class II ·Ongoing·Orthalign, Inc·April 1, 2026

    Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·March 18, 2026

    Impella RP Flex with SmartAssist. Product Code: 1000323.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

    Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Aesculap Inc·March 11, 2026

    Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·March 18, 2026

    Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·April 8, 2026

    Impella RP with SmartAssist. Product Code: 0046-0035.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

    MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light

    FDA Enforcement
    Class II ·Ongoing·MRIMed Inc.·March 4, 2026

    Impella RP. Product Code: 0046-0011.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·February 18, 2026