BEUDAMED
    109 results · 13ms · Sources: EU EUDAMED, US FDA

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    Dimension Vista Prolactin (PRL) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFT·March 21, 2017

    Dimension Vista Prolactin (PRL) Flex reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017

    Dimension Vista Digoxin (DIGXN) Flex reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017

    Dimension Vista Estradiol (E2) Flex reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017

    Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017

    Dimension Troponin 1 (TNI) Flex reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017

    Dimension Vista Estradiol (E2) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·March 21, 2017

    Dimension Troponin 1 (TNI) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MMI·March 21, 2017

    Dimension Vista Digoxin (DIGXN) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KXT·March 21, 2017

    Dimension Vista Ferritin (FERR) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DBF·March 21, 2017

    Dimension Vista Ferritin (FERR) Flex reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017

    Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 4, 2018

    Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·March 21, 2017

    Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·November 9, 2017

    LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length LSM0800626 6mm 26 mm 80 cm LSM1350626 6 mm 26 mm 135 cm LSM0800637 6 mm 37 mm 80 cm LSM1350637 6 mm 37 mm 135 cm LSM0800726 7 mm 26 mm 80 cm LSM1350726 7 mm 26 mm 135 cm Product Usage: The LIFESTREAM Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesions lengths up to 100mm.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code PRL·February 18, 2019

    Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  Correction of varus, valgus, or posttraumatic deformity.  Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.  The device is a single use implant intended for implantation with bone cement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 26, 2016

    Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JWH·August 9, 2016

    PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

    PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

    PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007