16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
UNIVERSIX 190
FDA 510(k)
FDA Class 1
·Radiology
LEVEL ONE
FDA UDI
KLS-Martin L.P.·00888118118233·
LEVEL ONE
FDA UDI
KLS-Martin L.P.·00888118118226·
E-Z-GUARD MOUTHPIECE
FDA 510(k)
FDA Class 1
·Anesthesiology
Discovery NM/CT 670 CZT
FDA 510(k)
FDA Class 2
·Radiology
PREMICATH PICC
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·May 20, 2015
PREMICATH PICC
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·May 22, 2015
PREMICATH
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·April 20, 2015
PREMICATH
FDA Adverse Event
VYGON GMBH·Product code LJS·April 20, 2015
PREMICATH PICC
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·June 3, 2015
PERFECTO2 V WITH SENSOR 9153650799
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 30, 2015
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 13, 2014
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·February 9, 2013
THERMA CARE
FDA Adverse Event
Injury
·PROCTER & GAMBLE PAPER PRODUCT CO·Product code IMD·March 6, 2002
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023