8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE ANTI-TG AB
FDA 510(k)
FDA Class 2
·Immunology
APC anti-human CD20
FDA UDI
BIOLEGEND, INC.·00810034700452·URL: https://www.biolegend.com/en-us/products/a...
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
neuromate Gen III
FDA 510(k)
FDA Class 2
·Neurology
BIOSTEON WEDGE INTERFERENCE SCREW
FDA Adverse Event
Malfunction
·BIOCOMPOSITES LTD.·Product code HWC·February 1, 2013
AMPLATZER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·January 31, 2011
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 2, 2014
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