BEUDAMED
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    AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE 800508330 NAIL TIB DYN 08X33.0 - STERILE 800508345 NAIL TIB DYN 08X34.5 - STERILE 800508360 NAIL TIB DYN 08X36.0 - STERILE 800508375 NAIL TIB DYN 08X37.5 - STERILE 800508390 NAIL TIB DYN 08X39.0 - STERILE 800508405 NAIL TIB DYN 08X40.5 - STERILE 800508420 NAIL TIB DYN 08X42.0 - STERILE 800509255 NAIL TIB DYN 09X25.5 - STERILE 800509270 NAIL TIB DYN 09X27.0 - STERILE 800509285 NAIL TIB DYN 09X28.5 - STERILE 800509300 NAIL TIB DYN 09X30.0 - STERILE 800509315 NAIL TIB DYN 09X31.5 - STERILE 800509330 NAIL TIB DYN 09X33.0 - STERILE 800509345 NAIL TIB DYN 09X34.5 - STERILE 800509360 NAIL TIB DYN 09X36.0 - STERILE 800509375 NAIL TIB DYN 09X37.5 - STERILE 800509390 NAIL TIB DYN 09X39.0 - STERILE 800509405 NAIL TIB DYN 09X40.5 - STERILE 800509420 NAIL TIB DYN 09X42.0 - STERILE 800510255 NAIL TIB DYN 10X25.5 - STERILE 800510270 NAIL TIB DYN 10X27.0 - STERILE 800510285 NAIL TIB DYN 10X28.5 - STERILE 800510300 NAIL TIB DYN 10X30.0 - STERILE 800510315 NAIL TIB DYN 10X31.5 - STERILE 800510330 NAIL TIB DYN 10X33.0 - STERILE 800510345 NAIL TIB DYN 10X34.5 - STERILE 800510360 NAIL TIB DYN 10X36.0 - STERILE 800510375 NAIL TIB DYN 10X37.5 - STERILE 800510390 NAIL TIB DYN 10X39.0 - STERILE 800510405 NAIL TIB DYN 10X40.5 - STERILE 800510420 NAIL TIB DYN 10X42.0 - STERILE 800511270 NAIL TIB DYN 11X27.0 - STERILE 800511285 NAIL TIB DYN 11X28.5 - STERILE 800511300 NAIL TIB DYN 11X30.0 - STERILE 800511330 NAIL TIB DYN 11X33.0 - STERILE 800511345 NAIL TIB DYN 11X34.5 - STERILE 800511360 NAIL TIB DYN 11X36.0 - STERILE 800511375 NAIL TIB DYN 11X37.5 - STERILE 800511390 NAIL TIB DYN 11X39.0 - STERILE 800511405 NAIL TIB DYN 11X40.5 - STERILE 800511420 NAIL TIB DYN 11X42.0 - STERILE 800512270 NAIL TIB DYN 12X27.0 - STERILE 800512285 NAIL TIB DYN 12X28.5 - STERILE 800512300 NAIL TIB DYN 12X30.0 - STERILE 800512315 NAIL TIB DYN 12X31.5 - STERILE 800512330 NAIL TIB DYN 12X33.0 - STERILE 800512345 NAIL TIB DYN 12X34.5 - STERILE 800512360 NAIL TIB DYN 12X36.0 - STERILE 800512375 NAIL TIB DYN 12X37.5 - STERILE 800512390 NAIL TIB DYN 12X39.0 - STERILE 800512405 NAIL TIB DYN 12X40.5 - STERILE 800512420 NAIL TIB DYN 12X42.0 - STERILE 800513285 NAIL TIB DYN 13X28.5 - STERILE 800513300 NAIL TIB DYN 13X30.0 - STERILE 800513315 NAIL TIB DYN 13X31.5 - STERILE 800513330 NAIL TIB DYN 13X33.0 - STERILE 800513345 NAIL TIB DYN 13X34.5 - STERILE 800513360 NAIL TIB DYN 13X36.0 - STERILE 800513375 NAIL TIB DYN 13X37.5 - STERILE 800513390 NAIL TIB DYN 13X39.0 - STERILE 800513405 NAIL TIB DYN 13X40.5 - STERILE 800513420 NAIL TIB DYN 13X42.0 - STERILE Product Usage: A rod, when inserted into the intramedullary canal of the tibia, acts as an immobilization device to hold ends of a fractured bone in position.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 4, 2018

    AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 810508345 NAIL TIB DYN 08 X 34.5 810508360 NAIL TIB DYN 08 X 36.0 810508375 NAIL TIB DYN 08 X 37.5 810508390 NAIL TIB DYN 08 X 39.0 810508405 NAIL TIB DYN 08 X 40.5 810508420 NAIL TIB DYN 08 X 42.0 810509255 NAIL TIB DYN 09 X 25.5 810509270 NAIL TIB DYN 09 X 27.0 810509285 NAIL TIB DYN 09 X 28.5 810509300 NAIL TIB DYN 09 X 30.0 810509315 NAIL TIB DYN 09 X 31.5 810509330 NAIL TIB DYN 09 X 33.0 810509345 NAIL TIB DYN 09 X 34.5 810509360 NAIL TIB DYN 09 X 36.0 810509375 NAIL TIB DYN 09 X 37.5 810509390 NAIL TIB DYN 09 X 39.0 810509405 NAIL TIB DYN 09 X 40.5 810509420 NAIL TIB DYN 09 X 42.0 810510255 NAIL TIB DYN 10 X 25.5 810510270 NAIL TIB DYN 10 X 27.0 810510285 NAIL TIB DYN 10 X 28.5 810510300 NAIL TIB DYN 10 X 30.0 810510315 NAIL TIB DYN 10 X 31.5 810510330 NAIL TIB DYN 10 X 33.0 810510345 NAIL TIB DYN 10 X 34.5 810510360 NAIL TIB DYN 10 X 36.0 810510375 NAIL TIB DYN 10 X 37.5 810510390 NAIL TIB DYN 10 X 39.0 810510405 NAIL TIB DYN 10 X 40.5 810510420 NAIL TIB DYN 10 X 42.0 810511255 NAIL TIB DYN 11 X 25.5 810511270 NAIL TIB DYN 11 X 27.0 810511285 NAIL TIB DYN 11 X 28.5 810511300 NAIL TIB DYN 11 X 30.0 810511315 NAIL TIB DYN 11 X 31.5 810511330 NAIL TIB DYN 11 X 33.0 810511345 NAIL TIB DYN 11 X 34.5 810511360 NAIL TIB DYN 11 X 36.0 810511375 NAIL TIB DYN 11 X 37.5 810511390 NAIL TIB DYN 11 X 39.0 810511405 NAIL TIB DYN 11 X 40.5 810511420 NAIL TIB DYN 11 X 42.0 810512270 NAIL TIB DYN 12 X 27.0 810512285 NAIL TIB DYN 12 X 28.5 810512300 NAIL TIB DYN 12 X 30.0 810512315 NAIL TIB DYN 12 X 31.5 810512330 NAIL TIB DYN 12 X 33.0 810512345 NAIL TIB DYN 12 X 34.5 810512360 NAIL TIB DYN 12 X 36.0 810512375 NAIL TIB DYN 12 X 37.5 810512390 NAIL TIB DYN 12 X 39.0 810512405 NAIL TIB DYN 12 X 40.5 810512420 NAIL TIB DYN 12 X 42.0 810513255 NAIL TIB DYN 13 X 25.5 810513285 NAIL TIB DYN 13MM X 28.5CM 810513300 NAIL TIB DYN 13MMX30.0 CM 810513315 NAIL TIB DYN 13MM X 31.5 CM 810513330 NAIL TIB DYN 13 X 33.0 810513345 NAIL TIB DYN 13MM X 34.5 CM 810513360 NAIL TIB DYN 13 X 36.0 MM 810513375 NAIL TIB DYN 13MM X 37.5 CM 810513390 NAIL TIB DYN 13MMX39.0CM 810513405 NAIL TIB DYN 13MM X 40.5 CM 810513420 NAIL TIB DYN 13MM X 42 CM Product Usage: A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 4, 2018

    Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.

    FDA Enforcement
    Class II ·Ongoing·Abbott Laboratories·December 27, 2023

    CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·April 27, 2016

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Laboratories·April 30, 2025

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Laboratories·April 30, 2025

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby

    FDA Enforcement
    Class II ·Ongoing·Abbott Laboratories·April 30, 2025

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Laboratories·April 30, 2025

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Laboratories·April 30, 2025

    CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·April 10, 2019

    CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·March 15, 2017

    Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·October 30, 2019

    Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)

    FDA Enforcement
    Class II ·Terminated·Advanced Back Technologies, Inc.·June 17, 2015

    Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)

    FDA Enforcement
    Class II ·Terminated·Advanced Back Technologies, Inc.·June 17, 2015

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·September 25, 2024