BEUDAMED
    16 results · 8ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

    FDA Enforcement
    Class II ·Terminated·Nanosphere, Inc.·October 1, 2014

    LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H

    FDA Enforcement
    Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

    LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

    FDA Enforcement
    Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

    LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

    FDA Enforcement
    Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

    LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

    FDA Enforcement
    Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

    LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

    FDA Enforcement
    Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

    LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

    FDA Enforcement
    Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

    LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit

    FDA Enforcement
    Class II ·Ongoing·LSL Healthcare Inc.·February 4, 2026

    (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.

    FDA Enforcement
    Class II ·Terminated·BSN Medical Inc·June 15, 2022

    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·July 27, 2016

    SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·December 6, 2017

    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·December 6, 2017

    N Latex CDT Kit

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·September 5, 2018

    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·April 29, 2020

    Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.

    FDA Enforcement
    Class II ·Terminated·Arjo, Inc. dba ArjoHuntleigh·July 18, 2012

    Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.

    FDA Enforcement
    Class II ·Terminated·Arjo, Inc. dba ArjoHuntleigh·July 18, 2012