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    Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for use by qualified medical personnel only.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MSX·May 8, 2009

    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LXH·October 25, 2019

    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LXH·October 25, 2019

    OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

    FDA Recall
    Open, Classified ·IMPULSE DYNAMICS (USA) INC·Product code QFV·January 5, 2024

    Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JQP·May 9, 2017

    RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·February 21, 2012

    C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only 5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.

    FDA Recall
    Terminated ·Camlog Usa·Product code NHA·August 28, 2013

    VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JIX·July 15, 2014

    Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100. The Central Control Monitor (CCM) provides a centralized display of system information and on-screen control of all system devices. The CCM combines an embedded computer, a touchscreen, and a graphical user interface.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·January 12, 2009

    Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.

    FDA Recall
    Terminated ·Talladium Inc·Product code EIH·August 6, 2020

    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JFY·January 29, 2014

    ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·October 7, 2002

    Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 22, 2012

    Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 22, 2012

    Spectrum IQ Infusion Pump, Product Code 3570009

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·July 14, 2025

    Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, BRAINLAB CAMERA - ARDEQT269004A, BRAINLAB CAMERA - ARDEQT269004C, BRAINLAB CAMERA - ARDEQT269005A, BRAINLAB CAMERA - ARDEQT269005C, EQTBRB SAT12 - ARDSAT269000A, EQTBRB SAT13 - ARDSAT269001A, EQTFHS010 11 - ARDEQT239014A, EQTFHS010 SAT12 - ARDSAT239005A, EQTFHS010 SAT13 - ARDSAT239006A, EQTFHS010 SAT16 - ARDSAT239023A, EQTMHD231 - ARDEQT239013A, EQTMHD231 11 - ARDEQT239016A, EQTMHD231 16 - ARDEQT239023A, EQTMHD231 SAT12 - ARDSAT239013A, EQTMHD231 SAT13 - ARDSAT239014A, EQTMHS013 08 - ARD2EQT00010A, EQTMHS013 11 - ARDEQT239007A, EQTMHS013 14 - ARDEQT239008A, EQTMHS013 16 - ARDEQT239009A, EQTMHS013 SAT12 - ARDSAT239007A, EQTMHS013 SAT13 - ARDSAT239008A, EQTMHS021 11 - ARDEQT239010A, EQTMHS021 14 - ARDEQT239011A, EQTMHS021 16 - ARDEQT239012A, EQTMHS021 SAT12 - ARDSAT239009A, EQTMHS021 SAT13 - ARDSAT239010A, EQTSC07 SAT12 - ARD515031140A, EQTSC07 SAT13 - ARD515032140A, EQTSC07 SAT16 - ARD2SAT00120A, EQTSC07 SAT16 - ARDSAT229007A, EQTSHD 11 - ARDEQT229001A, EQTSHD SAT - ARD515031990A, EQTSHD SAT - ARD515032990A, EQTSPC12 08 - ARDEQT269008A, EQTSPC12 11 - ARDEQT269009A, EQTSPC12 SAT12 - ARDSAT269005A, EQTSPC12 SAT13 - ARDSAT269006A, EQTXHD127 08 - ARDEQT239026A, EQTXHD127 11 - ARDEQT239027A, EQTXHD127 16 - ARDEQT239028A, EQTXHD127 SAT12 - ARDSAT239021A, EQTXHD127 SAT13 - ARDSAT239022A, EQTXHS010 08 - ARD2EQT00030A, EQTXHS010 08 - ARDEQT239024A, EQTXHS010 10 - ARD2EQT00050A, EQTXHS010 11 - ARDEQT239017A, EQTXHS010 14 - ARDEQT239019A, EQTXHS010 16 - ARDEQT239020A, EQTXHS010 SAT12 - ARDSAT239015A, EQTXHS010 SAT13 - ARDSAT239018A, EQTXHS021 08 - ARDEQT239025A, EQTXHS021 11 - ARDEQT239018A, EQTXHS021 14 - ARDEQT239021A, EQTXHS021 16 - ARDEQT239022A, EQTXHS021 SAT12 - ARDSAT239019A, EQTXHS021 SAT13 - ARDSAT239020A, EQTXS3216 11 - ARDEQT239015A, EQTXS3216 SAT12 - ARDSAT239016A, EQTXS3216 SAT13 - ARDSAT239017A, HOR 14 XD2 - ARDEQT239006A, HOR 14 XD2 - ARDEQT239006C, HOR 14 XO - ARDEQT269002A, HOR 14 XO - ARDEQT269002C, HOR 14 XS0 - ARDEQT239004A, HOR 14 XS0 - ARDEQT239004C, HOR 14 XS1 - ARDEQT239005A, HOR 14 XS1 - ARDEQT239005C, HOR 16 XD2 - ARDEQT239003A, HOR 16 XD2 - ARDEQT239003C, HOR 16 XO - ARD267900080A, HOR 16 XO - ARDEQT269003A, HOR 16 XO - ARDEQT269003C, HOR 16 XS0 - ARDEQT239001A, HOR 16 XS0 - ARDEQT239001C, HOR 16 XS1 - ARDEQT239002A, HOR 16 XS1 - ARDEQT239002C, SAT BRAINLAB 12 - ARD515070110A, SAT BRAINLAB 12 - ARD515070110C, SAT BRAINLAB 13 - ARD515071110A, SAT BRAINLAB 13 - ARD515071110C, SAT BRAINLAB CAMERA - ARDSAT269000C, SAT BRAINLAB CAMERA - ARDSAT269001C, SAT BRAINLAB CAMERA - ARDSAT269003A, SAT BRAINLAB CAMERA - ARDSAT269003C, SAT BRAINLAB CAMERA - ARDSAT269004A, SAT BRAINLAB CAMERA - ARDSAT269004C, SAT CAM 12 - ARD515031880A, SAT CAM 12 - ARD515031880C, SAT CAM 13 - ARD515032880A, SAT CAM 13 - ARD515032880C, SAT MEDIA - ARD2SAT00210A, SAT MEDIA - ARD2SAT00220A, SAT MHD214 - ARDSAT239011A, SAT MHD214 - ARDSAT239012A, SAT ORCHID - ARDSAT229000A, SAT ORCHID - ARDSAT229000C, SAT ORCHID - ARDSAT229001A, SAT ORCHID - ARDSAT229001C, SAT ORCHID - ARDSAT229003A, SAT ORCHID - ARDSAT229003C, SAT ORCHID - ARDSAT229004A, SAT ORCHID - ARDSAT229004C, SAT ORCHIDE 12 - ARD515031991A, SAT ORCHIDE 12 - ARD515031991C, SAT ORCHIDE 12 - ARDSAT229005A, SAT ORCHIDE 12 - ARDSAT229005C, SAT ORCHIDE 13 - ARD515032991A, SAT ORCHIDE 13 - ARD515032991C, SAT ORCHIDE 13 - ARDSAT229006A, SAT ORCHIDE 13 - ARDSAT229006C, SAT PERF 258S - ARD515053130A, SAT PERF 258S - ARD515053130C, SAT SC 071 - ARD515031140C, SAT SC 071 - ARD515032140C, SAT SC07 HOR - ARD2SAT00120C, SAT SHD 12 - ARD515031990C, SAT SHD 13 - ARD515032990C, SAT SHD HOR - ARD2SAT00150A, SAT SHD HOR - ARD2SAT00150C, SAT SSD 13 - ARD515032080A, SAT SUP CAM 12 - ARD515031730A, SAT SUP CAM 13 - ARD515032730A, SAT XD 241 - ARD515031660A, SAT XD 241 - ARD515031660C, SAT XD 241 - ARD515032660A, SAT X

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FTD·November 8, 2023

    Stryker Medical cam bearing service parts, Stryker Medical, Portage, MI; Parts 0753-006-143, 0753-006-130 and 0853-006-130S. For Wheeled hospital stretcher.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FPO·August 10, 2009

    Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·February 26, 2014

    Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Deluxe Wide Stretcher Model, P/N 21465, Sechrist Industries, Inc., Anaheim, CA

    FDA Recall
    Terminated ·Sechrist Industries Inc·Product code FPO·October 31, 2007

    Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 21, 2012