8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LIFETEK IUI CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PAQ. 215x280x180/QT-HS80/CARDIOLINE 200
FDA UDI
AB MEDICA GROUP, S.A.·08428763077305·
PAINDOC
FDA 510(k)
FDA Class 2
·Neurology
NP Medical nCompass Extension Set with Stabilizing Base
FDA 510(k)
FDA Class 2
·General Hospital
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 10, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 6, 2014
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009