BEUDAMED
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    DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR30229041·Ball head retainer clasps 0,90 mm

    ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION

    FDA 510(k)
    FDA Class 2 ·Hematology

    WILLI GELLER CREATION AND LF PORCELAIN

    FDA 510(k)
    FDA Class 2 ·Dental

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN/ FORMERLY TYCO·Product code BTS·March 20, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2011

    EMBRACE PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·March 28, 2008

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIU·February 9, 2022

    M2A-MAGNUM MOD HD SZ 42MM 42MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·April 4, 2018

    M2A-MAGNUM PF CUP 48ODX42ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·April 4, 2018

    Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·October 2, 2013

    ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code LPO·November 18, 2003

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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