7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MICROPROTEIN REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PAX-FLEX3D, PHT-7000
FDA 510(k)
FDA Class 2
·Radiology
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
FDA 510(k)
FDA Class 1
·General Hospital
VIRTUOSO II VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Death
·ANIMAS CORPORATION·Product code LZG·January 17, 2013
REJUVENATE
FDA Adverse Event
Malfunction
·HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS·Product code MEH·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