19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
Lower ROC Pack for Herbst LL5 12mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199006820·
DIGORA Optime
FDA UDI
PaloDEx Group Oy·06430035872480·
APPLIANCE, FIXATION, NAIL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·August 18, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 5, 2016
EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HWC·September 23, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code HWC·September 1, 2015
LCP 4.5/5 BROAD 18HO L332 TI
FDA Adverse Event
Injury
·SYNTHES·Product code KTT·December 12, 2012
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 27, 2014
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 16, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2013
LOCKSCR Ø5 SELF-TAP L55 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·April 11, 2013
LOCKSCR Ø5 SELF-TAP L40 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·June 27, 2013
LOCKSCR Ø5 SELF-TAP L44 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·October 18, 2013
Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
APPLIANCE,FIXATION,NAIL
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code KTT·October 10, 2016
2.5MM DRILL BIT/QC/GOLD/110MM
FDA Adverse Event
Malfunction
·SYNTHES GRENCHEN·Product code KTT·September 5, 2017