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

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    PICC-FIX

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756393751·ANGIOGRAPHY PACK

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112328·SURG-I-BAND GREEN

    Champion+ Mini Tray

    FDA UDI
    T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810128460764·

    Champion+ Mini Tray, Catch All

    FDA UDI
    T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810128460771·

    Champion+ Mini Tray Lid

    FDA UDI
    T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810128460993·

    Champion+ Shoulder Instrumentation Tray

    FDA UDI
    T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810128460757·

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LGD·May 22, 2019

    Signia Small Diameter Reloads

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

    DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR

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

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 11, 2013

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM DE MEXICO S DE RL DE CV·Product code FNL·November 23, 2010

    3.75MM TAP (NON-CANNULATED)

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·July 2, 2014

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LGD·May 27, 2019

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LSR·September 17, 2019

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LSR·August 23, 2019

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024