BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00312061·

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0032061·CC/ Transition Dentine TD-B1

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·09010782023648·CC/ Transition Dentine TD-B1

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159019087·Jacobson Micro Needle Holder Round Handle

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159019094·Jacobson Micro Needle Holder Round Handle

    Agilis

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935108320·

    50 ML BD PLASTIPAK LUER-SLIP SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 3, 2020

    PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    STRYKER CORPORATION·04546540046536·Precision Thin (12.0 x 0.38 x 34.5mm)

    NA

    FDA UDI
    STRYKER CORPORATION·04546540401861·Micro Dual Cut (12.0 x 0.38 x 34.5mm)

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    ROLLATOR, SUPER LIGHT, 250 LB CAP

    FDA Adverse Event
    Other ·Product code ITJ·February 16, 2011

    CPT HIP SYSTEM FEMORAL STEM

    FDA Adverse Event
    Malfunction ·ZIMMER MANUFACTURING B.V.·Product code KWY·February 25, 2008

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    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

    VeriCal Calibrator Set

    FDA Recall
    Terminated ·BIOMERIEUX, INC.·Product code JPA·August 19, 2005

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024