417 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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KINETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 29, 2012
Sudan Black B
FDA classification
FDA Class 1
·Sudan Black B
HTZ Ltd
FDA registration
HTZ Ltd·1 product·🇬🇧 United Kingdom
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
OVERWATCH
FDA UDI
SPINAL ELEMENTS·00840916137595·OVERWATCH® CONNECTORS CADDY
Heel Stick Safety Lancet (HHZ-II, HHZ-III)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
Disposable Hemodialysis Access Catheter Set Single Lumen8F*05cm(Straight)
FDA UDI
Guangdong Baihe Medical Technology Co., Ltd.·06938634490376·
Disposable Hemodialysis Access Catheter Set Single Lumen8F*08cm(Straight)
FDA UDI
Guangdong Baihe Medical Technology Co., Ltd.·06938634490383·
Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*13cm(Straight)
FDA UDI
Guangdong Baihe Medical Technology Co., Ltd.·06938634491656·
ARIX Hand System Bone Plate
FDA UDI
Jeil Medical Corporation·08806390825726·
ARIX Hand System Bone Plate
FDA UDI
Jeil Medical Corporation·08809282810824·
Disposable Hemodialysis Access Catheter Set Single Lumen7F*08cm(Straight)
FDA UDI
Guangdong Baihe Medical Technology Co., Ltd.·06938634496248·
ARIX Hand System Bone Plate
FDA UDI
Jeil Medical Corporation·08806390826648·
MFR-150/180-HHz
FDA UDI
MED -FIBERS INC.·00855950006561·Surgical Laser Fiber 150/180/210/350 micron, ha...
MF-365/400-HHz
FDA UDI
MED -FIBERS INC.·00855950006448·Surgical Laser Fiber 365/400/470/580 micron, si...
MFR-200/240-HHz
FDA UDI
MED -FIBERS INC.·00855950006462·Surgical Laser Fiber 200/240/270/400 micron, si...
MF-150/180-HHz
FDA UDI
MED -FIBERS INC.·00855950006554·Surgical Laser Fiber 150/180/220/350 micron, si...
MFR-365/400-HHz
FDA UDI
MED -FIBERS INC.·00855950006486·Surgical Laser Fiber 365/400/470/580 micron, si...