BEUDAMED
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    BriefCase-Quantification

    FDA 510(k)
    FDA Class 2 ·Radiology

    6L3 Transducer

    FDA UDI
    SIEMENS MEDICAL SOLUTIONS USA, INC.·04056869003108·

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704515145·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694022705·FPS 2.7mm 6 Hole Oblique L Compression Plate Right

    "2.0/2.4MM" FRACTURE SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036036089·

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946029654·X SERIES ADVANCED, 12 LEAD W/INTERP, PACE, SPO2...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946062378·X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LE...

    Tiger Shark System

    FDA UDI
    Choice Spine, LP·00840996166041·TIGER SHARK,STERILE,STR,9X24X11,12 DEG

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694076982·FPS 2.7 6 Hole Oblique Right L Compression Plat...

    STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAGNETOM ESPREE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SILASTIC MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·DOW CORNING CORP.·Product code FTR·May 29, 1998

    TRILOGY ACETABULAR SYSTEM ELEVATED RIM LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWB·November 21, 2008

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Malfunction ·AV-REDWOOD CITY·Product code MGB·September 9, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 22, 2013

    OPTIFLUX 180NR DIALYZER FINISHED ASSY

    FDA Adverse Event
    Injury ·OGEDN MANUFACTURING·Product code KDI·May 1, 2006

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code QBJ·November 15, 2024

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018

    GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021