17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
FDA 510(k)
FDA Class 2
·Cardiovascular
IMDX FLU A/B AND RSV FOR ABBOTT M2000
FDA 510(k)
FDA Class 2
·Microbiology
XYLOS MACRO-POROUS SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 6, 2023
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code MPB·December 19, 2016
VERSAFITCUP ACETABULAR SHELL Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·June 16, 2017
CAPSURE PS SET SCREW
FDA Adverse Event
Injury
·SPINE WAVE, INC.·Product code MNI·May 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
ENDOPATH XCEL STABILITY SLEEVE FOR BLADELESS TROCAR - 12MM DIAMETER, 100MM LENGT
FDA Adverse Event
Death
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·September 16, 2008
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·August 1, 2018
COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code MPB·June 13, 2017
Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·January 14, 2020
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·January 14, 2020
COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code MPB·March 19, 2018
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·June 7, 2018
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·July 11, 2019