17 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828119849·GEN4 Direct Access
THREADED STEINMANN PINS, TROCAR POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016448·
STAXX(R) XD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
QUANTIVA
FDA 510(k)
FDA Class 2
·Radiology
OXF ANAT BRG RT SM SIZE 6 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·April 26, 2018
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
OXF UNI TIB TRAY SZ B RM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HRY·April 26, 2018
ALARIS SYRINGE 8110 SERIES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code FRN·June 5, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
ANATOMIC
FDA Adverse Event
Malfunction
·AMPLITUDE·Product code JWH·December 11, 2018
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·March 23, 2018
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. 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