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

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    LAITEST Medical Face Mask

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

    Avex CX

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205108739·Avex CX.018 LL4 (-12°T 2°A)

    HAWKEYE™ Vertebral Body Replacement (VBR)

    FDA UDI
    Choice Spine, LP·00840996100946·VBR,SPACER,12X14X35,0 DEG

    Nex-Link®

    FDA UDI
    ZIMMER BIOMET INC·00887868284694·Transverse Connector - 4 mm Rod - 35 mm

    LVIS

    FDA UDI
    Microvention, Inc.·00811425029985·Low-Profile Visualized Intraluminal Support

    LVIS

    FDA UDI
    Microvention, Inc.·00810170016332·Stent

    LVIS

    FDA UDI
    Microvention, Inc.·00812636022239·Stent

    LVIS

    FDA UDI
    Microvention, Inc.·00842429100974·Stent

    LVIS

    FDA UDI
    Microvention, Inc.·00810170019036·Stent

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586023828·

    2008K@HOME HEMODIALYSIS MACHINE

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

    COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS

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

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 24, 2014

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 17, 2011

    UNIVERSAL STEM 115X14MM FLUTED

    FDA Adverse Event
    Injury ·1219655 DEPUY-RAYNHAM·Product code JWH·July 9, 2013

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025

    Port-A-Cath Low Profile Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4035-24

    FDA Recall
    Terminated ·Deltec, Inc·Product code LJT·March 29, 2004

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017