43 results · 25ms · Sources: EU EUDAMED, 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