BEUDAMED
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    ALATUS VAGINAL BALLOON PACKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EUPALAMUS DEFLECTABLE STYLET, MODEL 01545

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VKMO 78000 3 QUADROX-I HMO 70000+VHK7000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

    VKMO 78000 #QUADROX-I HMO 70000+VHK7000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016

    TRIDENT 10° X3 INSERT 32MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·May 3, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 16, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATIVE CENTER-SILICON VALLEY·Product code GEX·May 2, 2011

    HAHN TAPERED IMPLANT 4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 12, 2022

    HAHN TAPERED IMPLANT 5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 17, 2022

    HAHN TAPERED IMPLANT 4.3 X 10MM

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 20, 2021

    HAHN TAPERED IMPLANT Ø4.3 X 10MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 8, 2022

    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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018