27 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
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
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
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
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
SOZO Bilateral Arm L-Dex Software
FDA Enforcement
Class II
·Ongoing·Impedimed Limited·November 1, 2023
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·November 6, 2024