17 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
All Purpose Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935102748·
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·December 9, 2015
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·January 8, 2016
ELEMENT-TL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
FDA 510(k)
FDA Class 2
·Dental
XPS HANDPIECE - VISAO
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 2, 2021
DRILL 3334800 VISAO 80K HANDPIECE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 1, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 7, 2011
PROFEMUR(R) COCR NECK
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KWA·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
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·June 9, 2016
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 7, 2022
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