8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THROMBELASTOGRAPH
FDA 510(k)
FDA Class 2
·Hematology
EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
NATURA 2 PC - DURAHESIVE (DH) CONVEX WAFER
FDA Adverse Event
Injury
·CONVATEC, INC.·Product code EXE·June 30, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 9, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 15, 2010
Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.
FDA Recall
Terminated
·Baxa Corporation·Product code LHI·May 8, 2009
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024