BEUDAMED
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    UNICONDYLAR KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Safco DENTA-SAFE DENTAL DAM

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063750173·Light (0.15mm-0.18mm thickness) 5" x 5", green,...

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120207411·Carbide, cone flat, excavating and fissure bur

    SteriBest

    FDA UDI
    Mastel Surgical Inc.·00642356004389·WOVEN WIRE MESH TRAY W/ DROP HANDLES & DOUBLE F...

    SteriBest

    FDA UDI
    INTERNATIONAL SURGICAL PRODUCTS INC·00810129330472·WOVEN WIRE MESH TRAY W/ DROP HANDLES & DOUBLE F...

    EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERCLOSE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code MGB·May 31, 2018

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·September 13, 2024

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·July 21, 2025

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·March 18, 2025

    COVIDIEN AV IMPULSE FOOT COMPRESSION COVER

    FDA Adverse Event
    Injury ·COVIDIEN·Product code JOW·March 21, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·March 16, 2011

    C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM

    FDA Adverse Event
    Injury ·CARDICA, INC.·Product code FZP·March 27, 2008

    Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Bone Marrow Biopsy Tray Catalog Number: 8917R1

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·August 1, 2024

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014