9 results · 19ms · Sources: EU EUDAMED, US FDA

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SERVO VENTILATOR 300A

FDA 510(k)
FDA Class 2 ·Anesthesiology

MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR

FDA 510(k)
FDA Class 2 ·Cardiovascular

RAPID Web

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

TFNA SCR PERF L85 TAN

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code HSB·June 29, 2017

PULSE GEN MODEL 103

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·February 20, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·January 25, 2011

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 8, 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