22 results
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21ms
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Sources: EU EUDAMED, US FDA
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Imola-Silverstone
FDA UDI
Altus Spine, LLC·00843210133904·SS Paddle Distractor 8mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190028·Tibial Tray Screw Drill Guide
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122155·KWire .028x4" (0.7x100mm)
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310080·Probe, 1.5 inch Ball, Lenke, Thoracic, Straight...
General Instrument
FDA UDI
ORTHOPEDIATRICS CORP.·00841132127100·3.0mm Cleaning Brush
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 24, 2020
INFINION CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 28, 2024
SURETEK
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·November 6, 2020
PIN DISTRACTOR
FDA Adverse Event
Malfunction
·SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC·Product code HWB·March 6, 2025
COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code FMT·March 12, 2010
PERMACOL 10X28 1.5MM
FDA Adverse Event
Malfunction
·COVIDIENT, FORMERLY TISSUE...·Product code FTL·April 3, 2013
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·April 27, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008
BD TEXIUM¿ NEEDLE-FREE SYRINGE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FMF·November 29, 2022
UNK - GUIDE/COMPRESSION/K-WIRES
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LRN·March 6, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022