BEUDAMED
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    DRIVEMEDICAL

    FDA UDI
    Drive Devilbiss Healthcare·00822383247793·BedsAccessories Product Description: SpectrumBe...

    EF1

    FDA UDI
    Medshape, Inc.·00810028397125·Bolt - Half Pin Fixation - 4mm

    EF1

    FDA UDI
    Medshape, Inc.·00810028397132·Bolt - Universal Half Pin Fixation

    CENTRELLA BED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FNL·September 16, 2025

    Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.

    FDA Enforcement
    Class II ·Ongoing·SEDECAL SA·May 8, 2024

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·March 12, 2026

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 11, 2026

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 10, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 9, 2026

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 17, 2018

    Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.

    FDA Recall
    Open, Classified ·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code IZL·January 22, 2024

    ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH·July 2, 2014

    ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.

    FDA Recall
    Terminated ·VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH FRIEDRICH-EBERT-STR. 1 BERGISCH GLADBACH Germany·Product code LHN·May 9, 2014

    UNK_ULTRACISION HARMONIC FOCUS

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 1, 2025

    PKS CUTTING FORCEPS

    FDA Adverse Event
    Injury ·GYRUS ACMI INC.·Product code HFB·April 15, 2014

    PKS CUT FORCEPS, 5MM, 33CM, 9-PIN

    FDA Adverse Event
    Injury ·GYRUS ACMI INC·Product code HFB·April 3, 2014

    PKS CUTTING FORCEPS

    FDA Adverse Event
    Injury ·GYRUS ACMI INC.·Product code HFB·April 15, 2014

    SHUMACHER BIOPSY/RNGURLRG-TPSTR240MM

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code HFB·November 6, 2021

    SPOON FORCEPS LONG,SERRAT

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HFB·May 13, 2022

    TISCHLEY BPSY FCPS 9-1/4IN WITH LOCK

    FDA Adverse Event
    Malfunction ·INTEGRA YORK, PA INC.·Product code HFB·September 18, 2015