BEUDAMED
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    AART SILICONE TUBING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Safco polycarbonate crowns

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310223063·Safco polycarbonate crowns #40 5/box

    2040 Ceramic Brackets

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746005640·COSMETIC 20/40 UL CUSP 018 T=0 A+8 R=0

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000444·2.3mm x 6mm Safety Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694062695·2.0 System x 6mm Emergency Screw Sterile Qty 5

    AUDIOSCAN VERIFIT, MODEL VF-1

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    VECTORVISION CT-FREE KNEE

    FDA 510(k)
    FDA Class 2 ·Neurology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code HCG·March 17, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 28, 2008

    TUBING SET

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·May 19, 2023

    TUBING SET

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·May 19, 2023

    INCLUSIVE TAPERED IMPLANT 3.2 MMD X 11.5 MML X 3.0 MMP

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 27, 2022

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·March 20, 2023

    Advisor Vital Signs Monitor (model 9200), catalog number 920654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1)3-lead 60 Hz ECG, standarn SPO2, Invasive pressure/temperature option, printer and battery.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018