BEUDAMED
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    QAB2A IGM ELISA KIT HRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    Healqu

    FDA UDI
    Healqu LLC·00819143020406·HEALQU Non-Woven Adhesive Border Foam Dressing ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694015790·1.6mm x 10mm OMI Orthodontic Anchor Screw

    OneCath

    FDA UDI
    COMPACTCATH, INC.·00852141007208·The OneCath Intermittent Urinary Catheter is a ...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450546109·

    Solidity Vertebral Body Replacement

    FDA UDI
    Ulrich Medical Usa, Inc.·00814386022392·End cap, Ø 16mm, 10°

    LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    LIVESURE METHAMPHETAMINE SCREEN TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TMC PSI Cut Guide System

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222358·Cut Guide

    Acapella One

    FDA UDI
    Choice Spine, LP·10885862244901·

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 31, 2017

    IMUFLEX DISPOSABLES

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION/TERUMO BCT·Product code KSR·March 26, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 21, 2011

    EBI TROCHANTERIC NAIL SYSTEM

    FDA Adverse Event
    Malfunction ·EBI·Product code HSB·March 25, 2008

    Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·February 24, 2016

    CELSITE

    FDA Adverse Event
    Injury ·B.BRAUN MEDICAL SAS - OWNER·Product code LJT·August 9, 2016

    Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code OVE·September 28, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018