12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
IQMARK DIGITAL HOLTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
Generic Buccal Tubes
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746153594·WELD TUBE INCONEL UL MOL 018 T-10 R6D 2MM
QED DIODE DETECTORS, MODELS 1112-1116
FDA 510(k)
FDA Class 2
·Radiology
VOCOM SILICONE SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SYNDEO SYRINGE PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code MEA·October 8, 2009
DLT TS CER HD 12/14 40MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LZO·April 2, 2013
POSEY KEEPSAFE DELUXE
FDA Adverse Event
Malfunction
·J. T. POSEY COMPANY·Product code KMI·March 18, 2011
IAB: 8FR-30 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·April 18, 2008
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·June 11, 2024
UNK XEN STENT
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·June 11, 2024
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020