BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    MEDLINE ANTI-REFLUX VALVE

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

    HHM

    FDA UDI
    Oticon A/S·05707131258366·H160, MINIRITE 312 WL STG HHM

    DR COMFORT

    FDA UDI
    DJO, LLC·00888912235617·Sheer ThighHs OT W 20-30 BLK L

    PARELL NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896022027·PARELL NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP

    Aileron Expandable Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000042·

    Aileron Expandable Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000035·

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837044008·Aileron Implant Plate, Medium, Thin Foot

    3M INTEGRATED CYCLER (110V) & (220V)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITEK 2 GRAM POSITIVE GATIFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523164462·L Ultracongruent Tibial Insert Trial with Anter...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101139·L CR E-MAXTM Vitamin E Ultracongruent Tibial In...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124213·L Ultracongruent Tibial Insert Trial Sz B 14mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101993·L CR MAXTM HXL Ultracongruent Tibial Insert Sz ...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144624·L CR UHMWPE Ultracongruent Tibial Insert Sz B 14mm

    VERSAFITCUP ACETABULAR SHELL Ø 50

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·August 31, 2016

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    QUANTUM? MAVERICK?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 29, 2013

    SYSTEM 6 PRECISION HANDPIECE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 11, 2011

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025