21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Young
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302731714011·Young Nylon Rubber Damn Frame, Endo Radiolucent...
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383552523·Gutta Percha Points is used to root canal filin...
NEUMOVENT GRAPHNET MODEL 3179L1V
FDA 510(k)
FDA Class 2
·Anesthesiology
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025
CAPSUREEPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVN·October 14, 2014
Z-LOOK3
FDA Adverse Event
Injury
·Z-SYSTEMS AG·Product code DZE·June 15, 2013
BRUNO ELECTRA-RICE II
FDA Adverse Event
Injury
·BRUNO INDEPENDENT LIVING AIDS·Product code ILK·February 12, 2007
MONOSYN QUICK
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 20, 2022
MONOMEND ST 4/0 18''(45CM) HR17 VPL .RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 5, 2026
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 8, 2025
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 9, 2025
MONOMEND ST5/0 18"(45CM)DSMP11(M)VPL.RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·January 2, 2023
MONOMEND ST5/0 18"(45CM)DSMP11(M)VPL.RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·January 2, 2023
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·February 11, 2026
MONOMEND ST 5/0 18''(45)DSMP13(M)VPL.RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 25, 2026
Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder Numbers: 21-1701-02/32/33/36/44/49/51/54/62/63/66/81 21-1702-02//49/51 21-1703-02/32/33/36/44/49/51/54/62/63/66/81 21-1704-02/32/33/36/44/49/51/54/62/63/66/81 21-1705-79 21-1706-79 21-1707-79 21-1711-01/02/03/06/14/50 21-1712-01/02 21-1713-01/02/03/06/14/50 21-1714-01/02/03/06/14/50 21-1715-19 21-1716-19 21-1717-19
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024