15 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ShockPulse-SE Lithotripsy System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292398·
NA
FDA UDI
KEY SURGICAL, INC.·10849771048760·K-Wires, Double trocar, .054-inch (1.4mm) diame...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659483941·K-Wire w. double end trocarpoint _x000D_...
K-Wire w. double end trocarpoint 1.40mm/152mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM710240·K-Wire w. double end trocarpoint
1.40mm...
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780360858·Integra® Miltex® Microsurgery Needle Holder, 7-...
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
KENZ CARDY302 MAX
FDA 510(k)
FDA Class 2
·Cardiovascular
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 14, 2013
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
INTERSTIM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·June 30, 2011
BD INTIMA-II 20GAX1.16IN PRN SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·March 7, 2025
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·July 1, 2020
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012