BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    UroLift System (UL400 and UL500)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COVAMAX RESORBABLE COLLAGEN MEMBRANE

    FDA 510(k)
    FDA Class 2 ·Dental

    NON-CONTACT TONOMETER, MODEL FT-1000

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    STEM EXTENSION

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·March 29, 2023

    STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·June 9, 2023

    LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 7, 2025

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·August 24, 2018

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWS·July 14, 2011

    CURLIN INFUSION IV PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICE GROUP·Product code FRN·May 30, 2013

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008

    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