6 results · 32ms · Sources: EU EUDAMED, US FDA

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Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional mobility to individuals who have difficulty walking.

FDA Recall
Terminated ·Invacare Corporation·Product code ITJ·April 6, 2012

Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

FDA Recall
Terminated ·SANTA JOY ORNAMENT & GIFTWARE CO 3rd Block Changtian Ind Hengli Town Dongguan City China·Product code RDZ·November 21, 2017

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

FDA Recall
Terminated ·Neusoft Medical Systems Co., Ltd. NO.·Product code JAK·August 31, 2016

NeuViz 64 Multi-slice CT Scanner Systems

FDA Recall
Terminated ·Neusoft Medical Systems Co., Ltd. NO.·Product code JAK·August 31, 2016

Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code DRE·November 3, 2011

Neusoft NeuViz 64 Multi-slice CT Scanner System

FDA Recall
Terminated ·Neusoft Medical System Co·Product code JAK·March 8, 2014