BEUDAMED
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    MAARC DENTAL - MTA Fast Set

    FDA UDI
    SHIVA PRODUCTS·08906110443732·MTA is used for creating apical plugs during ap...

    MAARC DENTAL-Calcium Hydroxide Powder (with Barium Sulphate)

    FDA UDI
    SHIVA PRODUCTS·08906110443619·Calcium hydroxide is used as an agent to induce...

    MAARC DENTAL-Calx-O

    FDA UDI
    SHIVA PRODUCTS·08906110440403·It is a water based white paste consisting of p...

    MAARC DENTAL -Rootfyx

    FDA UDI
    SHIVA PRODUCTS·08906110443039·Rootfyx (Bioceramic sealer) is used for root ca...

    MAARC DENTAL - Sealmax +

    FDA UDI
    SHIVA PRODUCTS·08906110443053·Sealmax+ is a MTA based Bioceramic root canal s...

    MAARC DENTAL-Calcium Hydroxide Powder

    FDA UDI
    SHIVA PRODUCTS·08906110440397·Calcium hydroxide is used as an agent to induce...

    Maarc dental - Articulating Paper

    FDA UDI
    SHIVA PRODUCTS·08906110440175·A diagnostic tool used in dentistry to highligh...

    MAARC DENTAL-Sealmax - R

    FDA UDI
    SHIVA PRODUCTS·08906110440007·Sealmax-R is a resin based root canal sealing m...

    MAARC DENTAL-Calahyd-RC

    FDA UDI
    SHIVA PRODUCTS·08906110440014·Calahyd – RC is a silicon oil based yellowish p...

    MAARC DENTAL-Sealmax +

    FDA UDI
    SHIVA PRODUCTS·08906110443060·Sealmax+ is a MTA based Bioceramic root canal s...

    MAARC DENTAL - Ceraseal-B

    FDA UDI
    SHIVA PRODUCTS·08906110440458·MAARC CeraSeal-B is MTA based Bio-ceramic Root ...

    MAARC DENTAL-MTA Fast set kit

    FDA UDI
    SHIVA PRODUCTS·08906110443145·MTA is used for creating apical plugs during ap...

    MAARC DENTAL-MTA Fast set (unidose kit)

    FDA UDI
    SHIVA PRODUCTS·08906110443152·MTA is used for creating apical plugs during ap...

    UNKNOWN LIGASURE INSTRUMENT

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GEI·February 2, 2026

    FREESTYLE LIBRE 2 PLUS

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code QBJ·July 28, 2025

    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), - Salmonella species, - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), - Yersinia enterocolitica. In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

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

    ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures.

    FDA Recall
    Terminated ·Remel, Inc.·Product code GMZ·July 18, 2002

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KXA·November 12, 2019

    UNKNOWN HIP FEMORAL AUGMENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 12, 2019

    ATELLICA IM HIV AG/AB COMBO (CHIV)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·July 15, 2024