303 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
FDA Recall
Open, Classified
·Kinova Inc·Product code IQZ·August 22, 2024
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
FDA Enforcement
Class I
·Ongoing·Kinova Inc·October 23, 2024
CINOVA MEDICAL INC.
FDA registration
CINOVA MEDICAL INC.·1 product·🇺🇸 United States
INOVA DIAGNOSTICS, INC.
FDA registration
INOVA DIAGNOSTICS, INC.·45 products·🇺🇸 United States
QUANTA Flash® aCL IgG Reagents
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950544203·1. 1 QUANTA Flash aCL IgG Reagent Cartridge
2....
QUANTA Flash® M2 (MIT3) Controls
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950730095·1. QUANTA Flash M2 (MIT3) Negative Control: Two...
QUANTA Flash® Calprotectin Reagents
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950907206·1. 1 QUANTA Flash Calprotectin Reagent Cartridg...
QUANTA Flash® RNP Calibrators
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950595717·1. QUANTA Flash RNP Calibrator 1: Two (2) barco...
QUANTA Flash® dsDNA Controls
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950601920·1. QUANTA Flash dsDNA Low Control: Two (2) barc...
QUANTA Flash® GBM Calibrators
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950595120·1. QUANTA Flash GBM Calibrator 1: Two (2) barco...
QUANTA Flash® Ro52 Controls
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950596660·1. QUANTA Flash Ro52 Negative Control: Two (2) ...
QUANTA Flash® DGP Screen Calibrators
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950595830·1. QUANTA Flash DGP Screen Calibrator 1: Two (2...
QUANTA Lite® LKM- 1 ELISA
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950593201·1. 1x LKM-1 ELISA microwell plate (12-1 x 8 wel...
QUANTA Flash® h-tTG IgA Controls
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950554493·1. QUANTA Flash h-tTG IgA Negative Control: Two...
NOVA Lite® ANCA Formalin Kit
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950594109·1. 20x12-well ANCA Neutrophil substrate slides ...
QUANTA Lite® Celiac DGP Screen ELISA
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950593324·1. 1x Celiac DGP Screen ELISA microwell plate (...
QUANTA Flash® DGP IgG Controls
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950594413·1. QUANTA Flash DGP IgG Negative Control: Two (...
NOVA Lite® ANCA Kit
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950456216·1. 10x 6-well ANCA ethanol-fixed human neutroph...
NOVA Lite® ANCA (Ethanol) Kit with DAPI
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950602125·1. 20x ANCA (Ethanol Fixed Human Neutrophil), s...
QUANTA Lite® F-Actin IgA ELISA
FDA UDI
INOVA DIAGNOSTICS, INC.·08426950594093·1. 1x F-Actin ELISA microwell plate (12-1 x 8 w...