BEUDAMED
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    IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158211827·FORCEPS DEBAKEY ATRAUMATIC TISSUE 2MM TIP STRAI...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180153097·Debakey Forceps 9-1/2" Str 2mm

    AMT MINI ONE® EXTENSION SET

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL TECHNOLOGY, INC.·Product code PIF·December 7, 2023

    LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112

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

    Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    LONG NAIL KIT R1.5, LEFT 10X260MM X 125

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 16, 2010

    MINI ONE

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL TECHNOLOGY, INC.·Product code PIF·January 5, 2024

    SOLUSET 150 X 60 BURETTE SET, LATEX FREE

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPK·November 6, 2008

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·September 1, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019