BEUDAMED
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    7D Surgical System - Drill Guide

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010513687·INTUBATION PAD

    Zodiac

    FDA UDI
    ALPHATEC SPINE, INC.·00844856003347·TI 5.5MM TELESCOPING BRIDGE, 55MM

    Inertia® Pedicle Screw and Deformity Correxxion® System

    FDA UDI
    NEXXT SPINE, LLC·00889929027264·MAC Pedicle Screw, Ø10.5x55 mm

    ARCOMXL ACTIVE ARTICULATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JAX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIGNA 1.5 ECHO

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS, LLC·Product code LNH·August 10, 2011

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·October 29, 2014

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 17, 2019

    CHECKPOINT, 3.5MM HEX X 15MM, STERILE

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 29, 2016

    MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·March 15, 2017

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    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

    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