12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ultraxx Nephrostomy Balloon Catheter Set
FDA 510(k)
FDA Unclassified
·Unknown
ULTRAXX NEPHROSTOMY BALLOON AND SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJE·August 8, 2024
LIPCOLLECTOR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERTEBRAL ACCESS SYSTEM BY VIDACARE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RESTORATION ADM X3 INSERT FOR RESTORATION ADM CUP
FDA Adverse Event
Malfunction
·STRYKER·Product code JDI·July 22, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 21, 2013
MSD - UNKNOWN INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK MANUFACTURING·Product code JDN·September 17, 2008
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·December 19, 2017
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020