BEUDAMED
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    STINGRAY EPIDURAL CATHETER CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HairCheck-DT (Amphetamines)

    FDA UDI
    Quest Diagnostics·00868586000230·HairCheck-DT (Amphetamines) is an ELISA test ki...

    Medstone

    FDA UDI
    Stille AB·07332339230395·Float activation control for EU size standard s...

    TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DELTA 16 TACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/5H SHAFT/LT-STER

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·April 10, 2019

    PROCLEIX ULTRIO ELITE ASSAY

    FDA Adverse Event
    Injury ·GRIFOLS DIAGNOSTIC SOLUTIONS INC.·Product code QHO·August 15, 2025

    SECURA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·April 10, 2013

    MAXIMO II DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·April 12, 2011

    LIFEPAK 20 DEFIBIRLLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·May 22, 2008

    GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·January 26, 2009

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014