12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A
FDA 510(k)
FDA Class 2
·Radiology
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00842180149168·ELMED TELESCOPIC BRIDGES - 1 INSTRUMENT CHANNEL
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003490·15 Hole Comminuted Fracture Plate
Merit® Kit
FDA UDI
Merit Medical Systems, Inc.·00884450292235·
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
FDA 510(k)
FDA Class 3
·Cardiovascular
MEDCOM RT-VIEWER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
2124215-2014-16429
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVY·October 3, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 25, 2011
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 29, 2013
ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code MIH·August 25, 2020
ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
FDA Adverse Event
Death
·WILLIAM COOK EUROPE·Product code MIH·October 5, 2022
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013