9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TELETOM
FDA 510(k)
FDA Class 1
·General Hospital
AXSOS
FDA UDI
Stryker GmbH·07613327087871·Tag Titanium 5.0mm Screws
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022827·PRLS TPL 10 UPR GING -10X22 0X22X45RT
TORRENT IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
FDA 510(k)
FDA Class 2
·Orthopedic
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
XPANDER II
FDA Adverse Event
Malfunction
·KYPHON NEUCHATEL·Product code HRX·February 3, 2013
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 17, 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