BEUDAMED
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    Lab Bag with Fabric Pouch

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777457·LUMBAMED PLUS FLEX PAD WM SILVER III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777433·LUMBAMED PLUS FLEX PAD WM SILVER I

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777440·LUMBAMED PLUS FLEX PAD WM SILVER II

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·10884450390334·

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 29, 2022

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 7, 2023

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2023

    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    IMPLANTIUM

    FDA Adverse Event
    Injury ·DENTIUM·Product code DZE·October 22, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2013

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·February 12, 2024

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020