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

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    PS MEDICAL STRATA II VALVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809867220·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND CLOSED...

    SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MATRIXNEURO STERILE KIT STD 4

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JEY·December 19, 2013

    TI MATRIXNEURO BURR HOLE COVER24MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JEY·October 28, 2015

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 3, 2013

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 6, 2011

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 23, 2013

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code JEY·August 28, 2015

    NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·May 30, 2024

    PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    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