BEUDAMED
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    STARR FRAME STEINMANN PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VARISEED 7.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    RHIGENE MESACUP-2 TEST RNP, MODEL M7741

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEMEDIOX

    FDA Adverse Event
    Injury ·DEMETECH CORPORATION·Product code NEW·June 11, 2024

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 26, 2011

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·NORTH HAVEN - USS·Product code MFJ·July 23, 2008

    DEMEDIOX

    FDA Adverse Event
    Injury ·DEMETECH CORPORATION·Product code NEW·February 23, 2024

    DEMEDIOX

    FDA Adverse Event
    Injury ·DEMETECH CORPORATION·Product code NEW·February 23, 2024

    DEMEDIOX

    FDA Adverse Event
    Injury ·DEMETECH CORPORATION·Product code NEW·July 3, 2024

    DUREPAIR DURA SUBSTITUTE

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code GXQ·September 26, 2018

    AMPLATZER VASCULAR PLUG 4

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code KRD·December 14, 2017

    DEMEDIOX

    FDA Adverse Event
    Injury ·DEMETECH CORPORATION·Product code NEW·May 9, 2024

    DEMEDIOX

    FDA Adverse Event
    Injury ·DEMETECH CORPORATION·Product code NEW·February 23, 2024

    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Enforcement
    Class II ·Terminated·HF Acquisition Co., LLC·August 19, 2020

    Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).

    FDA Enforcement
    Class III ·Terminated·Smiths Medical ASD, Inc.·February 4, 2015

    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·May 8, 2013

    Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code MOI·March 8, 2017

    Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code MOI·March 8, 2017