BEUDAMED
    10 results · 18ms · 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 ×

    ALKPHASE-B ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981373·anteriors; shade D2; mould UL4

    EVOLVE EPS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Extended Lipid Panel Assay

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENDOPATH DILATING TIP TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GCJ·March 24, 1998

    UNI LFIT MEDIAL FEMORAL COMP.

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code HRY·April 15, 2013

    ACCU-CHEK ® AVIVA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·February 27, 2013

    STANDARD KOMPRESSOR SCREW 18 MM

    FDA Adverse Event
    Other ·INTEGRA LIFESCIENCES CORP. (INTEGRA-OHIO)·Product code HBL·February 3, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·August 5, 2014

    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