9 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UNIVERSITY PLATE ANTERIOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Assure® Lance Safety Lancets
FDA UDI
ARKRAY USA, INC.·00015482980283·Assure Lance Safety Lancets 28g 200's. Single-...
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
FDA 510(k)
FDA Class 2
·Dental
II-Type Intervertebral Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 27, 2013
COMPRESSION ANASTOMOSIS RING (CAR 27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·February 1, 2011
QUARTET
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·August 5, 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
Angiotech Galactography Kit. Galactography Kit 30ga with Straight Cannula and Galactography Kit 30ga with Curved Cannula. STERILE. Product Number: DGK002SX, DGK002X. 510k K980227. Qty Dist. - 2,630. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Injection Media Contrast Kit Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code FMI·September 1, 2009