15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
FDA 510(k)
FDA Class 2
·Microbiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003612·Long 6 Hole BSSO Plate
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036031848·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694064392·2.0 System 6 Hole Long BSSO Plate Sterile Qty 2
SYNTHES EXTERNAL MIDFACE DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
ESTHETICA
FDA 510(k)
FDA Class 2
·Dental
HAHN TAPERED IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 20, 2025
HAHN TAPERED IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 9, 2024
HAHN TAPERED IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 13, 2024
CAPSURE EPI
FDA Adverse Event
Death
·MPRI·Product code NVN·May 31, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 25, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·August 28, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·December 24, 2014
VERCISE? CARTESIA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code PJS·September 19, 2025
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