15 results
·
27ms
·
Sources: EU EUDAMED, US FDA
XENON LIGHT SOURCE PES 1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PICCOLO BASIC METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·October 22, 2020
PICCOLO COMPREHENSIVE METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·November 3, 2020
Kitazato ET Catheters
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
XIA 3 TITANIUM TORQUE WRENCH
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·March 7, 2013
ATTAIN ACCESS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DQY·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
BA102
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·March 31, 2016
BA105
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·March 28, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·August 29, 2017
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016