16 results · 19ms · Sources: EU EUDAMED, US FDA

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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