BEUDAMED
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    Enteral Feeding Set

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

    PosiSep C 0.6 x 2.0

    FDA UDI
    HEMOSTASIS, LLC·00858439001675·PosiSep C 0.6 x 2.0 devices are patient-comfort...

    SOLUTION SYSTEM

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295087243·SOLUTION SYSTEM FEMORAL GRAFT TAMP-OFFSET 26MM

    SYNTHES VA LCP ANKLE TRAUMA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    QUADROXI D PEDIATRIC OXYGENATOR

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DTZ·August 1, 2014

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code MAF·August 12, 2011

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    CR TIBIAL INSERT SZ4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 21, 2024

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·October 11, 2018

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 12, 2016

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·October 1, 2015

    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

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025