BEUDAMED
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    Freedom Primary PCK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583032986·ET20, KIT 312 NFM 85 PB R BE ENCHANT 20

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150591·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 200mm

    HAMILTON-C2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CURIEPACS (DICOM PACS SOFTWARE)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

    SYNCHRON LX® 20 PRO SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 4, 2011

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON SARL·Product code OTP·June 27, 2013

    PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·November 22, 2024

    PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·November 22, 2024

    PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·November 22, 2024

    PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·November 22, 2024

    bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014