15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 1220, OR E-NET (54-62 CM)
FDA 510(k)
FDA Class 2
·Neurology
ELECTROGLOTTOGRAPH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GE DATEX-OHMEDA AISYS
FDA 510(k)
FDA Class 2
·Anesthesiology
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·April 13, 2009
PRECISE OTW NITINOL STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·September 22, 2008
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 27, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2013
QUICK COUPLING FOR K-WIRES
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·July 28, 2014
PRECISE OTW NITINOL STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·August 11, 2008
ANGIOGUARD RX
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·June 9, 2010
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·October 30, 2008
AVIATOR PLUS PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code LIT·March 25, 2014
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIO·July 26, 2011
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DTK·August 17, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022