21 results · 24ms · Sources: EU EUDAMED, 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