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    TRI PAC MOUTH PROP

    FDA 510(k)
    FDA Class 2 ·Neurology

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750000722·VITROS Immunodiagnostic Products Free T4 Range ...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197491488·Titanium Blade 51x203...

    DRIVER SHAFT, T-15, LONG

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code LXH·November 13, 2018

    POWDER-FREE NITRILE GLOVES, BLACK

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection.

    FDA Recall
    Terminated ·Kerr Corporation·Product code FSP·April 10, 2012

    BIODESIGN TENSION FREE URETHRAL SLING

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code OTO·April 3, 2014

    PLATE

    FDA Adverse Event
    Death ·Product code HRS·October 17, 2012

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 28, 2007

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code HSD·September 13, 2019

    AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·April 3, 2017

    AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·September 6, 2016

    AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·October 19, 2016

    Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JQC·February 5, 2016

    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·August 21, 2017

    CellMek SPS Sample Preparation System, REF: C44603, with software

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code PER·December 23, 2025

    Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JQP·September 17, 2018

    DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code OYE·September 22, 2025

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021