5,979 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVANSYS MLP
FDA UDI
NEWDEAL·10381780044048·The NEWDEAL MLP Plate consists of an osteosynth...
ADVANSYS MLP
FDA UDI
NEWDEAL·10381780044024·The NEWDEAL MLP Plate consists of an osteosynth...
ADVANSYS MLP
FDA UDI
NEWDEAL·10381780044055·The NEWDEAL MLP Plate consists of an osteosynth...
ADVANSYS MLP
FDA UDI
NEWDEAL·10381780044031·The NEWDEAL MLP Plate consists of an osteosynth...
Advansys DLP/MLP
FDA UDI
NEWDEAL·10381780064374·The Advansys Midfoof Complete set includes Lisf...
Powered Laser Surgical Instrument－APOLLO V+ Medical Platform
FDA UDI
Beijing Syntech Laser Co., Ltd.·06970285176018·
Powered Laser Surgical Instrument－Nice Station Light Based Platform
FDA UDI
Beijing Syntech Laser Co., Ltd.·06970285176049·
Powered Laser Surgical Instrument－APOLLO IV+ Medical Platform
FDA UDI
Beijing Syntech Laser Co., Ltd.·06970285176025·
Powered Laser Surgical Instrument APOLLO IV+ Medical Platform
FDA UDI
Beijing Syntech Laser Co., Ltd.·06970285176148·
MLP Special Locking Bone Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)
FDA 510(k)
FDA Class 2
·Radiology
Ralco srl
FDA UDI
RALCO SRL·08058776050141·
MLP SYSTEM
FDA Adverse Event
Malfunction
·PHILLIPS MEDICAL SYSTEMS RADIOTHERAPY·Product code IYE·March 26, 1997
MCGHAN LIMITED MLP
FDA Adverse Event
Injury
·MCGHAN LIMITED / ALLERGAN·Product code FTR·April 30, 2019
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·August 15, 2022
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
FDA Enforcement
Class I
·Terminated·Abbott·May 23, 2018
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·March 27, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·January 13, 2023