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

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    IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551422519·FIVE S 3.5x65, sterile for single use

    NA

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551422533·FIVE S 3.5x65, sterile, for single use,

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450639917·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450562703·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450545744·

    DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JILCO TRACTION-FLEXION CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014

    EVIS EXERA III VIDEO SYSTEM CENTER

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·September 30, 2024

    FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·September 10, 2021

    FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·November 10, 2021

    SMALL ELECTRIC DRIVE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    2520274-2013-02317

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·May 3, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 28, 2014

    INFUSOMAT SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL INC.·Product code FRN·May 5, 2011

    Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 6, 2013

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012