10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIDAS RUB IGG
FDA 510(k)
FDA Class 2
·Microbiology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607351·SKYTRON 3600 2" STANDARD
NA
FDA UDI
STRYKER CORPORATION·07613327056631·Sliding-Lock Atraumatic Grasper, Single Action.
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
TRI-FIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ITOTAL G2
FDA Adverse Event
Malfunction
·CONFORMIS·Product code JWH·April 9, 2013
HARMONIC CURVED SHEARS INSERT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 6, 2011
RIGIFLEX II ACHALASIA BALLOON DILATOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNQ·July 23, 2008
INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·September 4, 2025
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