16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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12 RL ALGORITHM
FDA 510(k)
FDA Class 2
·Cardiovascular
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70603071·Mini-Mono-Brackets Roth 'N' .018" 9° 20 Bracket...
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024021·Paddle Shaver, 7mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103070·Shaver, Closed, 7mm
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707003753·Rumor .018 UL 4/5 -7T 0A 0O
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707003760·Rumor .018 UL 4/5 HK -7T 0A 0O
VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBH·December 16, 2016
LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DAVOL ARTHROVENT OUTFLOW TUBING
FDA 510(k)
FDA Class 2
·Orthopedic
CONFIDENCE KIT, NO NEEDLES
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NDN·April 1, 2014
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 11, 2013
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 15, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·June 12, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020