9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ADV400 TOE CPM
FDA 510(k)
FDA Class 1
·Physical Medicine
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515239777·Cottle Nasal Knife,5 1/4"
MFG-05
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEWPORT E500 WAVE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-BARCELONETA·Product code DQX·December 16, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2014
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020