7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADAPTING SLEEVE KIT MODEL 4023
FDA 510(k)
FDA Class 2
·Cardiovascular
XIVE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PROSOFT
FDA 510(k)
FDA Class 2
·Dental
TRILOGY O2
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·May 21, 2014
DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTW·January 17, 2013
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·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