16 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NPG + 2
FDA 510(k)
FDA Class 2
·Dental
1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·February 13, 2019
BMLS16-1
FDA 510(k)
FDA Class 2
·Neurology
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
FDA 510(k)
FDA Class 2
·Ophthalmic
LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·September 21, 2017
1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·February 13, 2019
1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·February 13, 2019
1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·February 13, 2019
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·February 21, 2013
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·January 20, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 1, 2014
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·February 28, 2018
1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·September 28, 2017
1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·May 25, 2017
1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·May 25, 2017
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·October 30, 2013