226 results · 20ms · Sources: EU EUDAMED, US FDA

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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

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

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

Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Stretcher Model, P/N : 21502, Sechrist Industries, Inc., Anaheim, CA

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

Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Deluxe Wide Stretcher Model, P/N 21464, 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, 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 21, 2012