BEUDAMED
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    Synergy

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARJORAD STERILE WRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OCTRODE LEAD KIT, 90CM LENGTH

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·March 21, 2023

    VANISHPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code MEG·October 21, 2022

    PROTEGE IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·September 20, 2022

    JAZZ LOCK

    FDA Adverse Event
    Malfunction ·IMPLANET·Product code OWI·February 16, 2026

    JAZZ LOCK

    FDA Adverse Event
    Malfunction ·IMPLANET·Product code OWI·February 16, 2026

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·October 29, 2014

    COLLEAGUE PRE P1.7

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    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

    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