BEUDAMED
    13 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system

    FDA Recall
    Open, Classified ·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 2025

    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

    FDA Recall
    Open, Classified ·Steris Corporation·Product code KQM·May 23, 2025

    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

    FDA Recall
    Open, Classified ·Product code DXJ·July 27, 2022

    Barco MDSC-8527 NXF, Part Number K9352421

    FDA Recall
    Open, Classified ·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code KQM·December 20, 2023

    ORAcollect RNA: ORE-100

    FDA Recall
    Open, Classified ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code QJR·February 18, 2022

    ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025

    FDA Recall
    Open, Classified ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code OYJ·February 18, 2022

    CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2112-0300-01; 5) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2111-0300-01; 6) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-51; 7) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 8) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-51; 9) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 10) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA, Model Number: 21-2111-0400-51; 11) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2111-0300-50; 12) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 13) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 14) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-78; 15) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 16) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2112-0300-00; 17) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-78; 18) PUMP, DEMO, CADD-SOLIS, MODEL 2100, NOT FOR HUMAN USE 1/EA, Model Number: 21-2101-249; 19) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-78; 20) PUMP KIT, CADD-SOLIS, YELLOW, MDL 2100 1/EA, Model Number: 21-2102-51; 21) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, NFHU, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-249; 22) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA, Model Number: 21-2111-0300-231; 23) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-78; 24) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0400-51; 25) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2112-0300-50; 26) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 27) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 28) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 29) PUMP, CADD-SOLIS, MODEL 2110, CE ENGLISH OUS 1/EA, Model Number: 21-2111-0100-50; 30) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 31) PUMP KIT, CADD-SOLIS HPCA, YELLOW KEYPAD, MODEL 2110, CE ENGLISH, OUS 1/EA, Model Number: 21-2112-0100-50; 32) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 33) PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA, Model Number: 21-2112-0400-01.

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code MEA·April 10, 2025

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code MEA·February 27, 2024

    CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA 21-2111-0300-09_FUK CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO 21-2111-0300-09_KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA 21-2111-0300-09_OKA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA 21-2111-0300-09_OMI CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA 21-2111-0300-09_OSA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO 21-2111-0300-09_SAP CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO 21-2111-0300-09_TOK CADD_SOLIS_MODEL 2110_ENGLISH_1/EA 21-2111-0200-50JP CADD-Solis VIP CADD-SOLIS V4.2 LOAN FUK 21-2111-0402-09-FUK CADD-SOLIS V4.2 LOAN NAG 21-2111-0402-09-NAG CADD-SOLIS V4.2 LOAN OKA 21-2111-0402-09-OKA CADD-SOLIS V4.2 LOAN OSA 21-2111-0402-09-OSA CADD-SOLIS V4.2 LOAN SAI 21-2111-0402-09-SAI CADD-SOLIS V4.2 LOAN SAP 21-2111-0402-09-SAP CADD-SOLIS V4.2 LOAN TOKE 21-2111-0402-09-TOKE CADD-SOLIS V4.2 LOAN TOKW 21-2111-0402-09-TOKW CADD-SOLIS V4.2 LOAN YELLOW KYO 21-2112-0402-09-KYO CADD-SOLIS V4.2 LOAN YELLOW NAG 21-2112-0402-09-NAG CADD-SOLIS V4.2 LOAN YELLOW YOK 21-2112-0402-09-YOK CADD-SOLIS V4.2 LOAN YOK 21-2111-0402-09-YOK Number:21-2111-0403-02Part Type:List Number/Finished GoodLifecycle Phase:03-ReleasedDescription:PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, FRENCH, 1/EA 21-2111-0403-02 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, YELLOW, ENGLISH, 1/EA 21-2112-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA 21-2111-0300-00 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DANISH 1/EA 21-2111-0300-12 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DUTCH 1/EA 21-2111-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, FRENCH 1/EA 21-2111-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, GERMAN 1/EA 21-2111-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, ITALIAN 1/EA 21-2111-0300-07 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, JAPANESE 21-2111-0300-09JP PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, FRENCH 1/EA 21-2111-0300-232 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA 21-2111-0300-231 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, SWEDISH 1/EA 21-2111-0300-244 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA 21-2111-0300-50 Not PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, PORTUGUESE 1/EA 21-2111-0300-17 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SPANISH 1/EA 21-2111-0300-08 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SWEDISH 1/EA 21-2111-0300-14 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, DUTCH 1/EA 21-2112-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, GERMAN 1/EA 21-2112-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA 21-2112-0300-00 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, DANISH 1/EA 21-2101-0200-12 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, FRENCH 1/EA 21-2101-0200-02 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, GERMAN 1/EA 21-2101-0200-03 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, ITALIAN 1/EA 21-2101-02

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code MEA·April 10, 2025

    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code MEA·June 26, 2024

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code MEA·February 27, 2024

    CADD Solis HSPCA Pump

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code MEA·April 10, 2025

    binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101

    FDA Recall
    Open, Classified ·Binx Health, Inc. 245 1st St Ste 18 Riverview II Cambridge MA 02142-1292·Product code QEP·March 29, 2023