BEUDAMED
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    SAFETY INTRODUCER NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tornier Latitude

    FDA UDI
    TORNIER, INC.·00846832019977·FLEXION/EXTENSION PIN

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776380694·Tendon Retriever, Straight, 1x2 teeth,Serrated,...

    SCFE Screw

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132114384·4.0mm X 35mm FULL THREAD CANNULATED SCREW

    Stryker

    FDA UDI
    Provision·B504TQ59210301350·

    Stryker

    FDA UDI
    HYGIA HEALTH SERVICES, INC.·10817357022169·30" x 4" Stryker Cuff - Royal Blue - Single Bla...

    MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PRO.DUCT CATHETER, MODEL CTH03

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

    Stryker Tourniquet

    FDA UDI
    RENU MEDICAL, INC·00816317024116·Stryker Color Cuff II Adt 30x4in. 5921-030-135

    Widex

    FDA UDI
    Widex A/S·05706069858471·COMPASS GPS 3.3 package (English)

    VC10 PUMP, 115V

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code HHK·January 2, 2025

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 2, 2013

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·March 28, 2011

    ACCU-CHEK TENDER INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FOZ·April 15, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - 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

    Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·April 5, 2023

    AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016

    Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-7006 SMI7010-7007 SMI7010-7008 SMI7010-7010 SMI7010-7011 SMI7010-7012 SMI7010-7015 STR5921-018-136 STR5921-018-235 STR5921-024-135 STR5921-024-136 STR5921-024-146 STR5921-024-235 STR5921-030-135 STR5921-030-235 STR5921-034-135 STR5921-034-136 STR5921-034-235 STR5921-044-135 STR5921-044-136 STR5921-044-235 STR5921-212-135 ZIM60-7070-02 ZIM60-7070-03 ZIM60-7070-04 ZIM60-7070-05 ZIM60-7070-06 ZIM60-7070-07 ZIM60-7070-101 ZIM60-7070-102 ZIM60-7070-103 ZIM60-7070-104 ZIM60-7070-105 ZIM60-7070-106 ZIM60-7070-107 ZIM60-7075-006 ZIM60-7075-03 ZIM60-7075-04 ZIM60-7075-05 ZIM60-7075-06 ZIM60-7075-07 ZIM60-7075-101 ZIM60-7075-102 ZIM60-7075-103 ZIM60-7075-104 ZIM60-7075-106 ZIM60-7075-107 ZIM60-7080-102 and ZIM60-7080-103 A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code KCY·August 8, 2008

    Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;

    FDA Recall
    Open, Classified ·Stryker Sustainability Solutions·Product code KCY·March 1, 2023