12 results
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19ms
·
Sources: EU EUDAMED, US FDA
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
2810 3WAY SLIDE VALVE
FDA UDI
HANS RUDOLPH, INC.·00874750009329·2810B 3WAY SLDVLV 1.125OD/22ID
Velocity™ Expandable Interbody System
FDA UDI
Spine Wave, Inc.·10840642106909·Expandable Implant, 22(L) X 10(W) X 8-14(H) 8 D...
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
FDA 510(k)
FDA Class 2
·Hematology
REPROCESSED TROCARS AND CANNULAS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
AMISTEM-H HA COATED LAT STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 19, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 19, 2011
ENDOPATH STEALTH CIR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FHM·August 11, 2008
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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025