10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
HEATWAVE
FDA 510(k)
FDA Class 2
·General Hospital
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AO/ASIF-QC F/TRS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·March 8, 2013
MULTI-LUMEN CVC KIT: 3-L FR X 6IN (16 C
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code FOZ·January 14, 2011
TRILOGY O2
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·July 23, 2014
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
FDA Adverse Event
Death
·STRYKER TRAUMA KIEL·Product code HSB·September 29, 2015
LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Recall
Terminated
·Zest Anchors LLC·Product code DZE·January 16, 2014
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Enforcement
Class II
·Terminated·Zest Anchors LLC·February 12, 2014
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015