BEUDAMED
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    GAMMA PHOTON GAMMA COUNTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SOL-M™ Luer Lock Syringe with Exchangeable Needle

    FDA UDI
    Sol-Millennium Medical, Inc.·00818392010039·Used to inject medicines and vaccines into, or ...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197494601·Micro Tumor Grasping Forceps Ø3,5mm...

    SONICFILL COMPOSITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·September 23, 2013

    SONICFILL COMPOSITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·September 23, 2013

    SONICFILL COMPOSITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·September 23, 2013

    SONICFILL COMPOSITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·September 23, 2013

    SONICFILL COMPOSITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·September 23, 2013

    ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    FUJIFILM 600 SERIES ENDOSCOPES

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

    FUJIFILM 600 SERIES ENDOSCOPE EC-600WM

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDF·January 22, 2025

    GEMSTAR PUMP 220V SP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 7, 2014

    MEGASUTURECUT NEEDLE DRIVER

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 14, 2012

    MYOCARDIAL LEAD

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2015

    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024