BEUDAMED
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    BAXANO NEURO CHECK DEVICE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SYNTHES PROXIMAL HUMERAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARFIL REPAIR

    FDA 510(k)
    FDA Class 2 ·Dental

    SECURE 3 MED/SURG BEDOBS 01/13

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 3, 2013

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014

    VANGUARD TIBIAL BEARING

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·May 10, 2011

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    ROD Ø5.5 SOFT CURV L70 TI

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 5, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    ROD Ø5.5 SOFT CURV L70 TI

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    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