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    Filters Classification: Class Ii ×

    Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA 224001026 M/DN R-F IM NAIL 10MM DIA 224001028 M/DN R-F IM NAIL 10MM DIA 224001030 M/DN R-F IM NAIL 10MM DIA 224001032 M/DN R-F IM NAIL 10MM DIA 224001034 M/DN R-F IM NAIL 10MM DIA 224001036 M/DN R-F IM NAIL 10MM DIA 224001038 M/DN R-F IM NAIL 10MM DIA 224001040 M/DN R-F IM NAIL 10MM DIA 224001042 M/DN R-F IM NAIL 10MM DIA 224001114 M/DN R-F IM NAIL 11MM DIA 224001116 M/DN R-F IM NAIL 11MM DIA 224001118 M/DN R-F IM NAIL 11MM DIA 224001120 M/DN R-F IM NAIL 11MM DIA 224001122 M/DN R-F IM NAIL 11MM DIA 224001124 M/DN R-F IM NAIL 11MM DIA 224001126 M/DN R-F IM NAIL 11MM DIA 224001128 M/DN R-F IM NAIL 11MM DIA 224001130 M/DN R-F IM NAIL 11MM DIA 224001132 M/DN R-F IM NAIL 11MM DIA 224001134 M/DN R-F IM NAIL 11MM DIA 224001136 M/DN R-F IM NAIL 11MM DIA 224001138 M/DN R-F IM NAIL 11MM DIA 224001140 M/DN R-F IM NAIL 11MM DIA 224001142 M/DN R-F IM NAIL 11MM DIA 224001144 M/DN R-F IM NAIL 11MM DIA 224001146 M/DN R-F IM NAIL 11MM DIA 224001218 M/DN R-F IM NAIL 12MM DIA 224001220 M/DN R-F IM NAIL 12MM DIA 224001224 M/DN R-F IM NAIL 12MM DIA 224001226 M/DN R-F IM NAIL 12MM DIA 224001228 M/DN R-F IM NAIL 12MM DIA 224001230 M/DN R-F IM NAIL 12MM DIA 224001232 M/DN R-F IM NAIL 12MM DIA 224001234 M/DN R-F IM NAIL 12MM DIA 224001236 M/DN R-F IM NAIL 12MM DIA 224001238 M/DN R-F IM NAIL 12MM DIA 224001240 M/DN R-F IM NAIL 12MM DIA 224001242 M/DN R-F IM NAIL 12MM DIA 224001244 M/DN R-F IM NAIL 12MM DIA 224001248 M/DN R-F IM NAIL 12MM DIA 224001318 M/DN R-F IM NAIL 13MM DIA 224001324 M/DN R-F IM NAIL 13MM DIA 224001326 M/DN R-F IM NAIL 13MM DIA 224001328 M/DN R-F IM NAIL 13MM DIA 224001330 M/DN R-F IM NAIL 13MM DIA 224001332 M/DN R-F IM NAIL 13MM DIA 224001334 M/DN R-F IM NAIL 13MM DIA 224001336 M/DN R-F IM NAIL 13MM DIA 224001338 M/DN R-F IM NAIL 13MM DIA 224001340 M/DN R-F IM NAIL 13MM DIA 224001344 M/DN R-F IM NAIL 13MM DIA 224001346 M/DN R-F IM NAIL 13MM DIA 224001348 M/DN R-F IM NAIL 13MM DIA 224001422 M/DN R-F IM NAIL 14MM DIA 224001436 M/DN R-F IM NAIL 14MM DIA 224001438 M/DN R-F IM NAIL 14MM DIA 224001440 M/DN R-F IM NAIL 14MM DIA 224001442 M/DN R-F IM NAIL 14MM DIA 224001444 M/DN R-F IM NAIL 14MM DIA 224001446 M/DN R-F IM NAIL 14MM DIA 224000922 M/DN R-F IM NAIL 9MM DIA 224000926 M/DN R-F IM NAIL 9MM DIA 224000928 M/DN R-F IM NAIL 9MM DIA 224000930 M/DN R-F IM NAIL 9MM DIA 224000932 M/DN R-F IM NAIL 9MM DIA 224000934 M/DN R-F IM NAIL 9MM DIA 224000936 M/DN R-F IM NAIL 9MM DIA 224000942 M/DN R-F IM NAIL 9MM DIA 224000946 M/DN R-F IM NAIL 9MM DIA 225320010 M/DN TIBIAL I/M NAIL 10MM 225326010 M/DN TIBIAL I/M NAIL 10MM 225328010 M/DN TIBIAL I/M NAIL 10MM 225330010 M/DN TIBIAL I/M NAIL 10MM 225332010 M/DN TIBIAL I/M NAIL 10MM 225334010 M/DN TIBIAL I/M NAIL 10MM 225336010 M/DN TIBIAL I/M NAIL 10MM 225338010 M/DN TIBIAL I/M NAIL 10MM 225344010 M/DN TIBIAL I/M NAIL 10MM 225320011 M/DN TIBIAL I/M NAIL 11MM 225322011 M/DN TIBIAL I/M NAIL 11MM 225324011 M/DN TIBIAL I/M NAIL 11MM 225326011 M/DN TIBIAL I/M NAIL 11MM 225328011 M/DN TIBIAL I/M NAIL 11MM 225330011 M/DN TIBIAL I/M NAIL 11MM 225332011 M/DN TIBIAL I/M NAIL 11MM 225334011 M/DN TIBIAL I/M NAIL 11MM 225336011 M/DN TIBIAL I/M NAIL 11MM 225338011 M/DN TIBIAL I/M NAIL 11MM 225340011 M/DN TIBIAL I/M NAIL 11MM 225342011 M/DN TIBIAL I/M NAIL 11MM 225344011 M/DN TIBIAL I/M NAIL 11MM 225346011 M/DN TIBIAL I/M NAIL 11MM 225328012 M/DN TIBIAL I/M NAIL 12MM 225330012 M/DN TIBIAL I/M NAIL 12MM 225332012 M/DN TIBIAL I/M NAIL 12MM 225334012 M/DN TIBIAL I/M NAIL 12MM 225336012 M/DN TIBIAL I/M NAIL 12MM 225338012 M/DN TIBIAL I/M NAIL 12MM 225340012 M/DN TIBIAL I/M NAIL 12MM 225346012 M/DN TIBIAL I/M NAIL 12MM 225324013 M/DN TIBIAL I/M NAIL 13MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures

    FDA Enforcement
    Class II ·Terminated·Opgen Inc·May 22, 2019

    AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.

    FDA Enforcement
    Class II ·Terminated·Advandx Inc·October 31, 2012

    M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014

    Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·October 10, 2012

    ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·November 25, 2015

    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025

    ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·January 24, 2018

    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025

    Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025