12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VICRYL Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032061·ET40 MNR T, 2.4G NFM DPB DG DEMO ENCHANT 40
EMBRACE
FDA 510(k)
FDA Class 2
·Radiology
SYNGO TRUED
FDA 510(k)
FDA Class 2
·Radiology
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021
UNI LFIT MEDIAL FEMORAL COMP.
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code HRY·April 15, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 21, 2014
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 28, 2011
NEU_INS_STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 27, 2019
POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F BASIC TRAY WITH MICROINTROD
FDA Adverse Event
Injury
·BARD ACCESS SYSTEMS·Product code LJS·December 6, 2018
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018