BEUDAMED
    20 results · 19ms · Sources: EU EUDAMED, US FDA

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    COULTER CLONE B4 MONOCLONAL ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Hematology

    Tricut®

    FDA UDI
    MEDTRONIC XOMED, INC.·20681490047573·BLADE 1884020 RAD 3PK AIRWAY LARYNGEAL

    Tricut®

    FDA UDI
    MEDTRONIC XOMED, INC.·20763000040301·BLADE 1884020 RAD 3PK AIRWAY LARYNGEAL

    NA

    FDA UDI
    Richard Wolf GmbH·04055207011287·TEM BASIS PART for TEM tubes, reusable

    Snowden-Pencer

    FDA UDI
    STERIS CORPORATION·10885403152641·Snowden-Pencer Plastics DIAMOND-TIP OSTEOTOMES ...

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989014051·LUG MOLAR LOOSE EA

    Reprocessed 4.0mm Tricut Straight-Tip Laryngeal Blade, 22.5cm

    FDA UDI
    SURETEK MEDICAL·B39018840201·

    Bioseal Inc.

    FDA UDI
    BIOSEAL·00630094188409·Sand Paper 150 Grit

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011884020180·dentaform® Band, Tooth 46, Size 20/Roth 18

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011884020000·dentaform® Band, Tooth 46, Size 20

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867047792·LO-PRO SCRW,SS 4.0X 20MMCANCLUS

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011884020220·dentaform® Band, Tooth 46, Size 20/Roth 22

    PYRIDOXAL DISC

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PEPTIC DIGEST AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CANES

    FDA Adverse Event
    PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IPS·June 19, 2014

    AVAIRA SPHERE ENFILCON A

    FDA Adverse Event
    Injury ·COOPERVISION MANUFACTURING LIMITED·Product code LPL·December 21, 2012

    OPTIVANTAGE DH

    FDA Adverse Event
    Injury ·LIEBEL-FLARSHEIM CO.·Product code IZQ·October 14, 2010

    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Xomed, Inc.·October 27, 2021

    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code EQJ·August 31, 2021

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014