BEUDAMED
    51 results · 19ms · 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 FDA Enforcement ×

    C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.

    FDA Enforcement
    Class II ·Ongoing·Iantrek Inc.·October 22, 2025

    Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek Usa, Inc - Dallas Distribution·December 2, 2015

    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek Usa, Inc - Dallas Distribution·May 11, 2016

    REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L

    FDA Enforcement
    Class II ·Ongoing·Compass Health Brands (Corporate Office)·April 26, 2023

    - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·October 1, 2014

    UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·October 1, 2014

    UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·October 1, 2014

    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 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm; (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm; (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm; (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm; (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm; (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm; (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.

    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 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.

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

    DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S

    FDA Enforcement
    Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026