10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KENSTONE
FDA 510(k)
FDA Class 1
·Physical Medicine
Hospira
FDA UDI
ICU Medical, Inc.·10887787003441·LIFESHIELD Extension Set, 6 Inch MicroCLAVE Cle...
ANKLE ARTHRODESIS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Zircos-Com
FDA 510(k)
FDA Class 2
·Dental
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·March 5, 2013
KAPPA 400 DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 7, 2014
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 9, 2021
ZIMMON PANCREATIC STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 16, 2020
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