BEUDAMED
    93 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·Ge Healthcare·September 9, 2020

    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

    FDA Enforcement
    Class II ·Ongoing·AGFA Healthcare Corp.·December 31, 2025

    Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

    FDA Enforcement
    Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·July 6, 2022

    Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)

    FDA Enforcement
    Class II ·Ongoing·Cartiva, Inc·December 11, 2024

    Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 17, 2024

    Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

    FDA Enforcement
    Class II ·Ongoing·Human Care Hc Sweden Ab·April 17, 2024

    Hanger-Bar 2P 45cm

    FDA Enforcement
    Class II ·Ongoing·Human Care USA, Inc.·April 6, 2022

    Hanger-Bar 2P 45cm

    FDA Enforcement
    Class II ·Ongoing·Human Care USA, Inc.·April 6, 2022

    Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

    FDA Enforcement
    Class II ·Ongoing·Intrinsic Therapeutics, Inc.·August 28, 2024

    Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021

    FDA Enforcement
    Class II ·Ongoing·Moller Vital·May 22, 2019

    Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003

    FDA Enforcement
    Class II ·Ongoing·Moller Vital·May 22, 2019

    Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 17, 2024

    ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·December 27, 2023

    NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.

    FDA Enforcement
    Class II ·Ongoing·NxStage MDS Corporation·March 6, 2024

    INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

    FDA Enforcement
    Class II ·Ongoing·PHASE SCIENTIFIC INTERNATIONAL LIMITED·January 24, 2024

    KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·February 5, 2025

    KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·February 5, 2025

    KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·February 5, 2025

    Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·January 22, 2025

    KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·February 5, 2025