BEUDAMED
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    Cios Select (VA21) Flat Panel

    FDA 510(k)
    FDA Class 2 ·Radiology

    TWINFIX

    FDA UDI
    Smith & Nephew, Inc.·03596010489029·TWINFIX 5.0 MM ABSORBABLE MATERIAL ...

    NA

    FDA UDI
    DEPUY MITEK, LLC·10886705000906·SuperAnchor Threader Tab

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551068204·BRAINLAB KIT: 2103-56, 2103-102, 2103-103, FOR ...

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024045·Paddle Shaver, 9mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103090·Shaver, Closed, 9mm

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 17, 2022

    FOB ONE STEP RAPID TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    BD PHASEAL¿ OPTIMA INJECTOR N35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 13, 2023

    ISOLATOR® SYNERGY SURGICAL ABLATION SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code OCL·July 28, 2025

    ACTIVA SC

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·August 9, 2011

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2013

    PARADIGM REAL -TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 13, 2014

    TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code MAI·September 9, 2020

    TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    PROGREAT LAMBDA

    FDA Adverse Event
    Malfunction ·TERUMO CLINICAL SUPPLY CO., LTD.·Product code DQO·February 27, 2025

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC2102 (Reorder No. 21-0309-01) 112 inch length/285 cm, 50ml priming volume, 12 drops/ml (at filter), 1 SureSite Prepierced injection site, 150 micron blood filter, 2 non-vented spikes

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

    FDA Enforcement
    Class I ·Ongoing·Whele LLC DBA Perch·November 30, 2022

    LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 6.5mm x 35mm; f. 6.5mm x 40mm; g. 6.5mm x 45mm; h. 6.5mm x 50mm; i. 6.5mm x 55mm; j. 7.5mm x 35mm; k. 7.5mm x 40mm; l. 7.5mm x 45mm; m. 7.5mm x 50mm; n. 7.5mm x 55mm; o. 8.5mm x 35mm; p. 8.5mm x 40mm; q. 8.5mm x 45mm; r. 8.5mm x 50mm; s.8.5mm x 55mm; t. 9.5mm x 35mm; u. 9.5mm x 40mm; v. 9.5mm x 45mm; w. 9.5mm x 50mm; x. 9.5mm x 55mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022