BEUDAMED
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    THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Aligned Medical Solutions

    FDA UDI
    Aligned Medical Solutions·B09800822410·General Utility Tray - RX

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180471·

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094112115·Welch Allyn Blood Pressure Cuff; Five-Cuff Kit:...

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094112184·Welch Allyn Blood Pressure Cuff; Five-Cuff Kit:...

    CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·December 17, 2018

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·December 5, 2023

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 29, 2013

    STERLING ES PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·May 9, 2011

    ACRYSOF TORIC

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code MJP·July 23, 2008

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·August 30, 2022

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·August 30, 2022

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·November 14, 2012

    NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-1 (10 pack/1 tube); Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance Tactics #30502-113S (case of 40/1tube); Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack); Firm on label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corporation, McGaw Park, IL 60085-6787 USA''

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·October 27, 2003

    NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-1 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-1 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-104-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-113S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-1 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-1- Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004