BEUDAMED
    15 results · 36ms · Sources: EU EUDAMED, US FDA

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    Reusable SpO2 Sensors, Disposable SpO2 Sensors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    High Density 144 Sublative iD (400 Pulse), 10-Pk

    FDA UDI
    SYNERON MEDICAL LTD·37290109952186·High Density 144 Sublative iD (400 Pulse), 10-Pk

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575297320·Neck Segment XXL,with collar (40 mm offset)

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575297313·Neck Segment XXL,with collar (40 mm offset)

    SYNTHES ZERO-P

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 6, 2012

    INFINION 16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 10, 2023

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 30, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 19, 2008

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·June 27, 2024

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·March 29, 2022

    Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    FDA Enforcement
    Class II ·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022