7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II
FDA 510(k)
FDA Class 2
·Orthopedic
SHAVER ABLATOR
FDA 510(k)
FDA Class 2
·Orthopedic
NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
5.0MM CANNULATED VA LOCKING SCREW/85MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·April 29, 2013
ANGLED LONG SABER ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·April 26, 2011
IN TOUCH ZX
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC, LP·Product code FNL·July 25, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014