BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    Automatic Blood Pressure Monitor Model LD-518 & LD-537

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVOLIX DUO LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CABLE TENSIONER WITH PISTOL GRIP

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·August 9, 2017

    CABLE TENSIONER WITH PISTOL GRIP

    FDA Adverse Event
    Malfunction ·RESOLVE SURGICAL TECHNOLOGIES·Product code LXH·December 30, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 21, 2011

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·June 12, 2013

    Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack

    FDA Enforcement
    Class II ·Ongoing·Windstone Medical Packaging, Inc.·January 11, 2023