BEUDAMED
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    U-STYLE ADAPTER

    FDA 510(k)
    FDA Class 1 ·Dental

    MGB Alert IC1 Internal Control Template (35uL volume)

    FDA UDI
    ELITECH GROUP INC.·03661540952371·The MGB Alert Internal Control Set IC1 consists...

    ADVIA Centaur® ACS:180® Calibrator A

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414555324·Thyroid (6PK) - CENTAUR - CAL - 6x2x5mL

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CRYOMINI

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SCREWDRIVER SOLERA RDN MAST

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 8, 2014

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 22, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 7, 2007

    S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.

    FDA Recall
    Terminated ·Beekley Corporation·Product code JAC·June 13, 2018

    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.

    FDA Recall
    Terminated ·Beekley Corporation·Product code JAC·June 13, 2018

    TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.

    FDA Recall
    Terminated ·Beekley Corporation·Product code JAC·June 13, 2018

    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·January 26, 2024

    FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

    FDA Recall
    Terminated ·BioFire Diagnostics, LLC·Product code QBH·April 16, 2021

    FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127

    FDA Recall
    Terminated ·BioFire Diagnostics, LLC·Product code PEN·July 20, 2021

    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

    FDA Recall
    Terminated ·BioFire Diagnostics, LLC·Product code PLO·September 10, 2018

    FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is growing in the blood culture. The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: Enterococci, Listeria monocytogenes, commonly encountered Staphylococci (including specific differentiation of Staphylococcus aureus), commonly encountered Streptococci (with specific differentiation of Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes), Acinetobacter baumannii, commonly encountered Enterobacteriaceae (including specific differentiation of the Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens), Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, and Candida tropicalis. The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (mecA), vancomycin (vanA and vanB), and carbapenems (blaKPC) to aid in the identification of potentially antimicrobialresistant organisms in positive blood culture samples.

    FDA Recall
    Terminated ·BioFire Diagnostics, Inc.·Product code PAM·May 27, 2014

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PEN·January 26, 2024

    FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)

    FDA Recall
    Terminated ·BioFire Diagnostics, LLC·Product code QDS·June 7, 2021