49 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·March 21, 2018
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·October 8, 2025
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
FDA Enforcement
Class II
·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
FDA Enforcement
Class II
·Ongoing·Medartis AG·June 17, 2026
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
FDA Enforcement
Class II
·Ongoing·Medartis AG·March 18, 2026
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
FDA Enforcement
Class II
·Ongoing·Medartis AG·March 18, 2026
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
FDA Enforcement
Class II
·Ongoing·Aesculap AG·October 8, 2025
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
FDA Enforcement
Class II
·Ongoing·Aesculap AG·October 8, 2025
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
FDA Enforcement
Class II
·Ongoing·Schiller, Ag·October 8, 2025
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
FDA Enforcement
Class II
·Ongoing·Schiller, Ag·September 4, 2024
Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-related disorders. isokinetic testing and evaluation system
FDA Enforcement
Class II
·Ongoing·Hocoma AG·July 1, 2020
Cirq Arm System 2.0
FDA Enforcement
Class II
·Ongoing·Brainlab AG·April 5, 2023
VADER pedicle system, torque wrench, Catalog Number 42-702
FDA Enforcement
Class II
·Ongoing·Icotec Ag·January 17, 2024
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).
FDA Enforcement
Class II
·Ongoing·SenTec AG·February 24, 2021
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
FDA Enforcement
Class II
·Ongoing·Brainlab AG·March 16, 2022
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
FDA Enforcement
Class II
·Ongoing·Brainlab AG·March 22, 2023
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
FDA Enforcement
Class II
·Ongoing·SenTec AG·September 27, 2023
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
FDA Enforcement
Class II
·Ongoing·Icotec Ag·December 28, 2022
VADER pedicle system, torque wrench, Catalog Number 42-703
FDA Enforcement
Class II
·Ongoing·Icotec Ag·January 17, 2024
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
FDA Enforcement
Class II
·Ongoing·SenTec AG·June 28, 2023