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

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    DISPOSABLE TRACHEAL TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Lifeshield

    FDA UDI
    ICU Medical, Inc.·10887787005124·LIFESHIELD, Microbore Extension Set - 5 Inch, P...

    Oticon

    FDA UDI
    Oticon A/S·05707131268969·RIA PRO, DESIGNRITE 10 WL STG

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780379331·Integra® Jarit® Lahey Gall Duct Forceps, 7-1/2"...

    Cancellous Screw, Cannulated

    FDA UDI
    I.T.S. GmbH·09120034302442·Cancellous Screw, Cannulated, D=4.0mm, L=28mm, ...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319740453·Sawtell Hemostatic Forceps 7-1/2" (18.8cm), ful...

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925015739·SCHEER PISTON 5.0 MM OVERALL LENGTH 3.83 MM FUN...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197051828·Pean Hemostatic Forceps 160mm,...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197051811·Pean Hemostatic Forceps 140mm, 5"

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197051804·PEAN Hemostatic Forceps, straight 12.5 c...

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 1, 2019

    VERSAPULSE MODEL P20 LASER SYSTEM

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

    MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 31, 2013

    COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·August 29, 2008

    HMX AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·June 26, 2011

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    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