9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·November 11, 2015
BONE BIOPSY SYSTEM
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS·Product code KNW·April 25, 1997
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 3, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 6, 2014
NA
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code GEI·July 18, 2013