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

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    CUSTOMED CYSTO PACK II

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

    Phantom Tibial Preparation

    FDA UDI
    ADLER ORTHO SPA·08052693623549·GENUS PANTHEON PHANTOM TIBIAL PREPARATION SZ.5

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083016623·STR, 10 electrode, MPD-DL, 2-5-2-5-2-5-2-5-2mm ...

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746111112·DB BKT MINI MS UR CUSP 018 T-7 A+7 R=0

    PRIMER PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF

    FDA 510(k)
    FDA Class 2 ·Neurology

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    PACING/PSI KIT: 5 FR 2-L

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code LDF·May 7, 2014

    LIGACLIP*MCA SMALL APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDO·January 8, 2013

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 12, 2010

    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·August 23, 2017

    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

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019