BEUDAMED
    21 results · 21ms · 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 ×

    NORIAN SRS BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70604081·Mini-Mono-Brackets Edgew. 'N' .022" 200 Brackets

    Osseofit™ Porous Tissue Matrix

    FDA UDI
    DSM BIOMEDICAL, INC.·00812337021531·

    ALARIS PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 16, 2020

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306813726·Graefe Dressing Forceps, Slight Curved, Serrate...

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K0600080·Try insert, InTess C Level 1

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0600080·Tray Insert, Lumbar Rods

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0600080·Tray Insert, Level I

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0600080·Tray Insert, Disc Prep 1

    BHR MODULAR HEAD 46MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018

    LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF

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

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2013

    SYNCHRON® LXI® 725 CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 16, 2011

    COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·June 12, 2008

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022