23 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES RESORABLE MESHES AND SHEETS
FDA 510(k)
FDA Class 2
·Orthopedic
ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX MODULAR HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MKJ·July 30, 2024
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·October 15, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·December 31, 2009
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 28, 2024
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·October 29, 2009
WALLFLEX¿ BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·March 14, 2013
UNKNOWN ZIMMER CR FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·February 24, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 12, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·August 13, 2010
ALLOFT-S ALLOCLASSIC SHL 52/II
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code JDI·March 12, 2019
ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 27, 2018
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016