BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    Stockert S5 System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00195377109866·NTS Outlier Tray

    Dilator, Vascular, acc. Garrett 19cm 5.0mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034047026·Dilator, Vascular, acc. Garrett 19cm 5...

    Ti-Fix OLIF Spacer

    FDA UDI
    Tyber Medical, LLC·M695P32101300·Ti-Fix OLIF Spacer 32 x 10 x 13 (mm) x 0 °

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C30422101300·PEEK PLIF Spacer, 22 x 10 x 13mm, 0 deg

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C31422101300·Titanium PLIF Spacer, 22 x 10 x 13mm, 0 deg

    Dilator, Vascular, acc. Garrett 19cm 5.0mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034047033·Dilator, Vascular, acc. Garrett 19cm 5...

    FALLER TROCAR

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

    POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103

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

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 30, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 20, 2008

    MACHINE, CRRT

    FDA Adverse Event
    Malfunction ·GAMBRO·Product code KDI·July 30, 2011

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 8, 2013

    CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)

    FDA Adverse Event
    Death ·CURRENT HEALTH LTD·Product code MSX·September 9, 2024

    OT SELECT SIMPLE METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 16, 2017

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-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 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.

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

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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