43 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLEXR PLUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELITE
FDA UDI
Smith & Nephew, Inc.·03596010512291·SUTURE NEEDLE SHUTTLE STERILE
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319722268·Tebbetts Style Self-Retaining Skin Hook 6" (15c...
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383543477·"An absorbent paper points is an endodontic pap...
VIGIL DNASE B CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PACEART OPTIMA SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
ELITE PASS DISPOSABL
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE·Product code HWQ·February 7, 2011
ELLIPSE DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 29, 2014
PARADYM
FDA Adverse Event
Injury
·SORIN C.R.M S.R.L.·Product code MRM·August 8, 2011
CURRENT ACCEL VR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
L3O0235 - S92S
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 14, 2020
L3O0235 - S92S
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 14, 2020
L3O0235 - S92S
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 14, 2020
L3O0235 - S92S
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 14, 2020
L3O0235 - S92S
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 14, 2020
L3O0235 - S92S
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 14, 2020
L3O0235 - S92S
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 14, 2020
L3O0235 - S92S
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 14, 2020