9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01
FDA 510(k)
FDA Unclassified
·Unknown
VARIAX
FDA UDI
Stryker GmbH·07613327091625·Screw Rack T10 3.5/2.7mm
PERSONAL WARMING LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
INIFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 22, 2010
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2014
UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KOB·May 2, 2018
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