BEUDAMED
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    SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LUME 2 SYSTEM, MODEL GA0005000

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

    CENTRICON CONCENTRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AXIOM ARISTOS VX PLUS

    FDA Adverse Event
    Injury ·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·June 25, 2014

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·February 28, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·February 10, 2011

    IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.

    FDA Recall
    Terminated ·Numed Inc·Product code LIT·September 23, 2009