BEUDAMED
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    CARESCAPE R860

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NA

    FDA UDI
    Smith & Nephew, Inc.·00885554010824·5.5 MM BLUNT OBTURATOR FOR 5.5 MM ...

    DG Gel 8 A/B/D

    FDA UDI
    DIAGNOSTIC GRIFOLS SA·08437014205930·The DG Gel 8 A/B/D card is for the determinatio...

    DG Gel 8 A/B/D

    FDA UDI
    DIAGNOSTIC GRIFOLS SA·08437014205039·The DG Gel 8 A/B/D card is for the determinatio...

    PROTECTOR, INJECTOR, CONNECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DILON 6800 ACELLA (ACELLA)

    FDA 510(k)
    FDA Class 1 ·Radiology

    PULSE GEN MODEL 101

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 8, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·August 8, 2014

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 8, 2013

    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

    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