BEUDAMED
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    ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs

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

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450414118·

    SURGICAL PROCEDURE PACKS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SOLA 700,SOLA 500, SOLA 300

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 26, 2024

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 17, 2025

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 15, 2024

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·October 23, 2008

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 12, 2011

    UNIFY CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Death ·DEXCOM, INC.·Product code MDS·June 25, 2016

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Death ·DEXCOM, INC.·Product code MDS·February 24, 2017

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FPA·April 20, 2026

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code MEA·March 6, 2024

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015