11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASFORA BULLET CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
2130 3 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750009367·2130C 3W STPK.187FB 15/10.5
ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
FDA 510(k)
FDA Class 2
·Cardiovascular
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 14, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 19, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 11, 2008
AMISTEM C, CEMENTED STEM SIZE 0 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·February 3, 2017
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021