29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496020769·RELAX UNISEX 70, SIZE S, BORDEAUX, GRADUATED CO...
Masimo Cable accessory kit(8 pin,Adu)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904086477·
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
KSEA MANHES PNEUMOTROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GAG·March 22, 2006
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·June 16, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·June 13, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code GCJ·June 8, 2006
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Instructions For Use (FI) HVAD¿ System Instructions For Use (FI) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Instructions For Use - FI HVAD¿ System Instructions For Use (FI) HVAD¿ System OUS Patient Manual (FI-Finnish) HVAD¿ System Emergency Responder Guide (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System OUS Instructions For Use (TR-Turkish)
FDA Enforcement
Class II
·Ongoing·Heartware, Inc.·May 25, 2022
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·June 19, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GCJ·June 8, 2006
45MM ARTICING LNR CUTR/BLUE RLD
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GCJ·December 21, 2005
ENDO LINEAR CUTTERS-ETS45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·June 8, 2006
ENDOPATH ETS-FLEX45 ARTICULATING ENDOSCOPIC LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 15, 2006
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 30, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 1, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 1, 2011
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM -
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·October 21, 2005
ETS 45 ENDO LINEAR CUTTER BL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·December 19, 2005