43 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP MMT-1884XC 780G V6.5 CLIN US MG;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP MMT-1886XC 780G V6.5 CLIN MG;¿ PUMP MMT-1885L MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886L MM780G 6.5W BLE MG;¿ KIT MMT-1896ES MM780G V6.5W MG;¿ KIT MMT-1896WWA MM780G BLE MG ES;¿ KIT MMT-1895WWA MM780G BLE MMOL AR;¿ KIT MMT-1895WWA MM780G BLE MMOL CS;¿ KIT MMT-1895WWA MM780G BLE MMOL DA;¿ KIT MMT-1895WWA MM780G BLE MMOL DE;¿ KIT MMT-1895WWA MM780G BLE MMOL EN;¿ KIT MMT-1895WWA MM780G BLE MMOL FI;¿ KIT MMT-1895WWA MM780G BLE MMOL FR;¿ KIT MMT-1895WWA MM780G BLE MMOL IT;¿ KIT MMT-1895WWA MM780G BLE MMOL NL;¿ KIT MMT-1895WWA MM780G BLE MMOL NO;¿ KIT MMT-1895WWA MM780G BLE MMOL SL; KIT MMT-1895WWA MM780G BLE MMOL SV;¿ KIT MMT-1895WWA MM780G BLE MMOL HU;¿ KIT MMT-1896WWA MM780G BLE MG AR;¿ KIT MMT-1896WWA MM780G BLE MG DE;¿ KIT MMT-1896WWA MM780G BLE MG EL;¿ KIT MMT-1896WWA MM780G BLE MG HE;¿ KIT MMT-1896WWA MM780G BLE MG IT;¿ KIT MMT-1896WWA MM780G BLE MG PL;¿ KIT MMT-1896WWA MM780G BLE MG RO;¿ KIT MMT-1896WWA MM780G BLE MG TR;¿ KIT MMT-1896WWA MM780G BLE MG NL;¿ KIT MMT-1896WWA MM780G BLE MG FR;¿ KIT MMT-1896WWA MM780G BLE MG ES;
FDA Enforcement
Class II
·Ongoing·Medtronic Minimed·June 9, 2021
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
FDA Enforcement
Class II
·Completed·Trumpf Medical Systems, Inc.·January 6, 2016
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·July 17, 2024
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·July 17, 2024
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·September 12, 2012
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·July 17, 2024
MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
MiniMed 620G Insulin Pump (MMT-1750)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
FDA Enforcement
Class II
·Ongoing·Allergan PLC·December 11, 2019
REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
FDA Enforcement
Class II
·Terminated·Allergan PLC·February 10, 2021
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Enforcement
Class II
·Ongoing·Nexstim PLC·June 14, 2017
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Enforcement
Class II
·Ongoing·Nexstim PLC·June 14, 2017
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F
FDA Enforcement
Class II
·Terminated·Covidien, PLC·March 27, 2019