BEUDAMED
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    Composi-Tight®

    FDA UDI
    GARRISON DENTAL SOLUTIONS, L.L.C.·00810038095417·3D Fusion™ Matrix System: (40) Firm Matrices, (...

    Composi-Tight 3D Fusion

    FDA UDI
    GARRISON DENTAL SOLUTIONS, L.L.C.·00810038090221·Composi-TIght 3D Fusion Firm Intro Kit

    Composi-Tight®

    FDA UDI
    GARRISON DENTAL SOLUTIONS, L.L.C.·00810038095615·3D Fusion™ Matrix System: (70) Firm Matrices, (...

    Composi-Tight®

    FDA UDI
    GARRISON DENTAL SOLUTIONS, L.L.C.·00810038095400·3D Fusion™ Matrix System: (70) Firm Matrices, (...

    Composi-Tight 3D Fusion Matrix System

    FDA UDI
    GARRISON DENTAL SOLUTIONS, L.L.C.·00810038090467·1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Fi...

    BAXTER CF1211 HHF/CA/0.8/L)

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORP.·Product code FJI·April 24, 1996

    BELLAVISTA

    FDA Adverse Event
    Injury ·IMTMEDICAL AG·Product code CBK·February 3, 2021

    INTRAUTERINE DEVICE (IUD)

    FDA Adverse Event
    Injury ·UNK·Product code HHF·July 14, 2022

    MIRENA

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE PHARMACEUTICALS·Product code HHF·April 20, 2023

    UNKNOWN

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code HHF·December 20, 2019

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Death ·ABBOTT MEDICAL·Product code NKM·September 23, 2022

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code NKM·September 23, 2022

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Death ·ABBOTT MEDICAL·Product code NKM·October 17, 2025

    TRICLIP DELIVERY SYSTEM (TCDS)

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code NPS·October 17, 2025

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code NKM·October 17, 2025

    TRICLIP DELIVERY SYSTEM (TCDS)

    FDA Adverse Event
    Death ·ABBOTT MEDICAL·Product code NPS·October 17, 2025

    Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·October 19, 2016

    Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code IYE·September 13, 2016

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code HHF·December 3, 2024

    Remover, Intrauterine Device, Contraceptive, Hook-Type

    FDA classification
    FDA Class 1 ·Remover, Intrauterine Device, Contraceptive, Hook-Type