BEUDAMED
    23 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 ×

    Advantage-C PEEK Cervical lnterbody Fusion Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257073353·PROTECT PATELLA TRACKING BRACE, RT, SM

    Kompressor™ Compression Screw System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780280309·STANDARD K WIRE DEPTH GAUGE

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857307957·Parallel Rasp Size: 18x45x6 mm

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586013355·PAC II TRAY, EPIDURAL, LP, PU, 1.2MM/CS 1/EA

    TLC Uni Knee Femoral Implant

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215077235·

    n/a

    FDA UDI
    Ortho Development Corporation·00822409067923·Stem Extension Trial Diameter 21x150mm

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    ENDOPOUCH RETRIEVER

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

    I-LIPO SYSTEM

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

    Echotip

    FDA UDI
    COOK INCORPORATED·00827002162990·Echotip Disposable Amniocentesis Needle

    Echotip

    FDA UDI
    COOK INCORPORATED·00827002182035·Echotip Disposable Amniocentesis Needle

    TAXUS (R) LIBERTÉ (R)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 15, 2011

    GATEWAY PTA DILATION CATHETER

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code GBA·October 22, 2008

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 8, 2013

    Port-A-Cath II Low Profile Epidural Implantable Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 0.5mm I.D., REF 21-1501-01

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

    Port-A-Cath II Epidural Low Profile Polysulfone/Titanium Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 5mm I.D., REF 21-1501-22

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

    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline from a syringe to the AccuLIF implant for in-situ expansion. The Tubing Set attaches to the AccuLIF Insertion handle at two district locations: the "junction block" and the "manifold." The PL and TL Tubing Sets are Class 2 instruments not intended to sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·March 2, 2016