8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
JR. MICROCOAGULATION SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
AXSOS
FDA UDI
Stryker GmbH·07613327089271·Plate Tray with lid Single Layer
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LANX ANTERIOR CERVIAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
A.S. HUMERAL STEM 12 UNCEMENTED
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·June 18, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 3, 2013
LIFECARE PCA 3 V5.06
FDA Adverse Event
Injury
·HOSPIRA, INC.·Product code MEA·December 20, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020