12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOFIX EXO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517630674·CoRoent Ant TLIF Ti, 13x12x40mm 15°
NA
FDA UDI
Medos International Sàrl·10886705011179·ACORN REAMER, STERILE 20 - 130mm (Plus or Minus...
PPA/BT-RB STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
GIVEN DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 12, 2023
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·March 31, 2009
INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 31, 2009
POLY-L-LACTIC ACID (POLY-L-LACTIC ACID)
FDA Adverse Event
Injury
·AVENTIS PHARMA GRUPPO LEPETIT S.R.L.·Product code LMH·August 26, 2011
TROCAR CATH 8FR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code DRC·September 17, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025