BEUDAMED
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    electrocardiograph: SE-1202

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00195377109880·NTS Tubes Tray, Slotted

    SOFTSILK CLEAR-TRAC

    FDA UDI
    Smith & Nephew, Inc.·00885554011425·SOFTSILK SCR 2.0 7X20 IN CANN LTX (1)

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515036031·Sheehan Gouge, 2mm, 6 1/4"

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319744468·Graefe (Iris) Hook 5" (12.5cm), sharp, delicate

    Dilator, Vascular, acc. Garrett, set 21cm (12 sizes 0.5-9.0mm)

    FDA UDI
    Geister Medizintechnik GmbH·04057034047088·Dilator, Vascular, acc. Garrett, set 21cm (...

    Ti-Fix OLIF Spacer

    FDA UDI
    Tyber Medical, LLC·M695P32101400·Ti-Fix OLIF Spacer 32 x 10 x 14 (mm) x 0 °

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C30422101400·PEEK PLIF Spacer, 22 x 10 x 14mm, 0 deg

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C31422101400·Titanium PLIF Spacer, 22 x 10 x 14mm, 0 deg

    HRH-127 HEAD ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    NEUROVISION NERVE LOCATOR MONITOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021

    HEYER-SCHULTE

    FDA Adverse Event
    Injury ·HEYER-SCHULTE·Product code FTR·August 22, 2000

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,4

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 20, 2008

    FINELINE II

    FDA Adverse Event
    Death ·CPI - DEL CARIBE·Product code NVN·August 12, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 3, 2013

    NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LJE·May 28, 2013

    NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·July 17, 2013

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 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. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.

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