8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SILICONE PUNCTAL PLUG
FDA 510(k)
FDA Unclassified
·Unknown
NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RANIR PLAX RX
FDA 510(k)
FDA Class 1
·Dental
11.0MM TI HELICAL BLADE 90MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·September 24, 2015
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 7, 2013
SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code FQH·December 28, 2010
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2014
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