BEUDAMED
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    Avitus(r) Bone Harvester

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777488·LUMBAMED PLUS FLEX PAD M SILVER I

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010588524·MTO TREPHINE ADAPTOR 12MM

    QMedix™

    FDA UDI
    Diagnostic Automation, Inc.·10850054026986·QMedix™ Benzodiazepines Urine RapiDip InstaTest...

    NEMIO

    FDA 510(k)
    FDA Class 2 ·Radiology

    VENNER TRACHEAL SEAL MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OP CO·Product code OZO·October 25, 2014

    COLLEAGUE PRE P1.7

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

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 8, 2013

    BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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