BEUDAMED
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    ASPIRA PERITONEAL DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PALACOS®

    FDA UDI
    Heraeus Medical GmbH·04260102136182·The PALACOS® R+G pro system consists of a mixin...

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810057370854·STRETCHER PAD 30" W X 3.5" H X 76" L SOFTCARE PLUS

    TC-PLUS POROUS TIBIAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DR180-II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    UNKNOWN FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.1818910·Product code JDI·April 26, 2013

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 24, 2008

    HAHN TAPERED IMPLANT 5.0 X 8 MM

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 3, 2021

    Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026

    INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 29, 2022

    HAHN TAPERED IMPLANT 4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 3, 2022

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 24, 2021

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 16, 2022

    HAHN TAPERED IMPLANT 4.3 X 10MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 31, 2022

    Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 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