9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Oral-B iO Test Drive Power Brush Trial Program Kit
FDA 510(k)
FDA Class 1
·Dental
HARRINGTON RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075245·HARRINGTON RETRACTOR
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
FDA 510(k)
FDA Class 2
·General Hospital
PERFADEX SOLUTION FOR ORGAN PRESERVATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAD-5V PULSE OXIMETER
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·September 17, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 30, 2011
XIA 3 TITANIUM TORQUE WRENCH
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·July 2, 2013
UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·July 23, 2020
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016