13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGISLEEVE WOUND PROTECTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Embla
FDA UDI
S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD·07290013817143·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003575·Straight Reconstruction Plate
Merit® Kit
FDA UDI
Merit Medical Systems, Inc.·00884450322420·
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL - FLARSHEIM CO.·Product code IXR·May 29, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 25, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·August 27, 2008
EQUINOXE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·January 9, 2024
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