14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
DIGOXIN ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ALLEVYN AG DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
ACETATE-FREE DIALYSLATE SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
D901 LILLIPUT OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·October 13, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·February 15, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 19, 2011
MICROMAX-PLUS MOTOR ASSEMBLY
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·December 13, 2013
CUSTOM PERFUSION PACK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 30, 2012
LILLIPUT 1 START
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 17, 2023
LILLIPUT 1 OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALY·Product code DTZ·December 27, 2024
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 6, 2024
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·January 17, 2022
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·January 25, 2022
Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part numbre PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017