9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
JAYCO HYDROGEN MONITOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65888824991·PLASTIC PACK
INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
C. DIFF QUIK CHEK COMPLETE
FDA 510(k)
FDA Class 1
·Microbiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2014
1.3MM TI Y-PLATE/3 HOLES HEAD 8 HOLES SHAFT/32MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·October 21, 2010
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 20, 2012
Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026