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

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    Widefield OCT software feature for the Spectralis HRA+OCT and variants

    FDA Enforcement
    Class II ·Terminated·Heidelberg Engineering·May 2, 2018

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.

    FDA Enforcement
    Class II ·Terminated·Summit Medical, Inc.·December 23, 2015

    Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-500-025.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0531-200-250.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0535-400-225.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF 0535-400-210.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-200-050.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheter, sterile, REF 0532-400-225.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10 in. catheters, sterile, REF 0532-400-210.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5" catheter, sterile, REF 0531-200-025.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0535-400-250.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-500-050.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, sterile, REF 0535-626-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-200-025.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0532-400-250.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, sterile, REF 0531-216-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0532-526-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0535-426-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

    Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, standard catheter, sterile, ; REF 0531-216-001.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009