BEUDAMED
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    Liver Suite

    FDA 510(k)
    FDA Class 2 ·Radiology

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551111986·HALO, 1203-5 VEST MEDIUM, ACRYLIC LINER, 1211-1...

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221048905·Unitek(TM) Permachrome Standard Stainless Steel...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197040174·Super-Cut Metzenbaum-Freeman Scissors curved...

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·January 9, 2002

    VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CT/MASTER, VERSION 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD EMERALD¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 15, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·August 15, 2011

    75MM SELECTABLE NEW TLC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 8, 2013

    CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026