26 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031424·1.6mm Modified LeFort Plate, Right, 2mm
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481114038·LOCATOR R-Tx Abutment for Regular Platform Tiss...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776392505·Tissue Forceps, 2x3 teeth, 6"
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780378273·Integra® Jarit® Tissue Forceps, 4-5/8", Standar...
MODIFICATION TO EXPORT ASPIRATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EXPLOR RADIAL HEAD PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857559981·Straight Curette Size 2 mm
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD220881302010·8 3/4" Malis Bayonet Bipolar Forceps with Irrig...
TREU
FDA UDI
TREU-Instrumente GmbH·04048447299478·Dynamic Screw 3,2mm/100mm/30mm Thread BrainLAB ...
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD221081302010·10 3/4" Malis Bayonet Bipolar Forceps with Irri...
VANISHPOINT
FDA Adverse Event
RETRACTABLE TECHNOLOGIES·Product code MEG·June 24, 2013
UNKNOWN PRODUCT - SET SCREW
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·May 24, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 30, 2014
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·June 10, 2011
MBT CEM TIBIAL TRAY SZ3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·May 8, 2017
LCS COMPLETE FEM POR L STD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·May 8, 2017
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016