BEUDAMED
    21 results · 27ms · 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 ×

    4CIS® Marlin ACIF Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mouthpiece, Disposable, 1-1/16" O.D., 2.625" L

    FDA UDI
    A-M SYSTEMS, LLC·00817081023657·Mouthpiece, Disposable, 1-1/16" O.D., 2.625" L

    Echo® Hip System Instrumentation

    FDA UDI
    Biomet Orthopedics, LLC·00887868474521·

    ECHO(TM) HIP SYSTEM INSTRUMENTATION

    FDA UDI
    Biomet Orthopedics, LLC·00880304463448·

    EASYSTAND EVOLV

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014

    M2A-MAGNUM PF CUP 54ODX48ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 11, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025

    G4 STEERABLE GUIDING CATHETER

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code DRA·October 14, 2022

    VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

    FDA Enforcement
    Class II ·Terminated·VGI Medical, LLC·June 13, 2018

    SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code MAX·March 19, 2012

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017