13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SI-TECHNOLOGY® SI-DESIS® SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837087982·
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 4, 2022
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 6, 2022
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962101902·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 10m...
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 6, 2022
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: CERCON BASE
FDA 510(k)
FDA Class 2
·Dental
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962104118·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 10m...
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
PLUM A+ DRIVER NEW 8
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD·Product code FRN·May 30, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014