16 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517390172·CoRoent XL Sizer, 14x18x45mm 10°
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756353502·NEURO ANGIO PACK PGYBK
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158218703·SCISSOR STANDARD BLUNT/BLUNT STRAIGHT 5.75"
H.A.M., 14-Channel w/ blank insert holes
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024732·
H.A.M.,14-Chan w blank insert holes,Slot
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024749·
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
FDA 510(k)
FDA Class 3
·Cardiovascular
DIRECTVISION CATHETER, UNCOATED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUADRA P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 12, 2026
OPEN SPINE ANGLED CLAMP
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 14, 2013
QUADRA P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 26, 2025
PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·November 22, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·January 11, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 2, 2014
BD PLASTIPAK 50ML LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 17, 2019
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