13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATHWAY
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605531·MAQUET 1130 ORTHOPEDIC 3.25" DELUXE GEL
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450573334·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450160688·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197500692·VATS MICS Chest Tube Passer
WL 280...
NA
FDA UDI
STRYKER CORPORATION·07613327052701·Insert, Tapered Bullet Dissector
WALLSTENT ENTERNAL PROSTHESIS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
FDA 510(k)
FDA Class 3
·Cardiovascular
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 5, 2023
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·April 24, 2013
STANDARD EXPANSION CLIP MARK III
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 6, 2011
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 22, 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