BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    PANPAC WORD/BARTHOLIN CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TISSUE FORCEPS FOX CURVED

    FDA UDI
    W.H. Holden, Inc.·D9281300870·

    COVAMAX RESORBABLE COLLAGEN MEMBRANE

    FDA 510(k)
    FDA Class 2 ·Dental

    SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DORMA 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 16, 2022

    CSF-PERITONEAL CATHETER, STANDARD, OPEN END WITH SLITS

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·May 21, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·August 19, 2008

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 26, 2016

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016

    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 4, 2022

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·June 15, 2016

    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015