BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517570291·CoRoent Ant TLIF Ti, 13x11x28mm 0°

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116022724·Dornier 600 µm Single-Use SMA Diode Laser Fiber...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111164439·SKLRLTE SKLARCUT METZ CVD 5.75

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180183605·PRISM SPINE CURETTE, 10", STRAIGHT 0, GREEN

    Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed

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

    ULTRA-DRIVE 3

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRILL, AO, STERILE 4, 2X340 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011

    OPTILITE® FREELITE® KAPPA FREE KIT

    FDA Adverse Event
    Injury ·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026

    OPTILITE® FREELITE® KAPPA FREE KIT

    FDA Adverse Event
    Injury ·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026

    ULTRA DRIVE 6MM PLUG PULLER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDX·July 20, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 1, 2011

    SIG C/R POROCOAT FEM RT SZ 3

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code MBH·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014