11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DURAL DISSECTORS
FDA 510(k)
FDA Class 1
·Neurology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756349260·BASIC LAP PACK
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450225691·
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
VERDICT -II METHAMPHETAMINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 30, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 2, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 19, 2012
CIRCUIT PED 5FT DUAL-HTD 20/CS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BZE·June 1, 2012
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