22 results
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20ms
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Sources: EU EUDAMED, US FDA
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
FDA 510(k)
FDA Class 2
·Cardiovascular
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383507899·Gutta Percha Points is used to root canal filin...
Zavation
FDA UDI
Zavation LLC·00842166106253·ALIF 15deg 36mmx17
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575268597·Proximal tibial spacer, uncemented, Ti6Al4V, fo...
ZAVATION
FDA UDI
Zavation LLC·00842166154964·WHITNEY 15deg 36mmx17mm
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575183517·Proximal tibial spacer, uncemented, Ti6Al4V, fo...
ZAVATION
FDA UDI
Zavation LLC·00842166157187·HA+ ALIF 15deg 36mmx17
Zavation
FDA UDI
Zavation LLC·00842166180635·ALIF Sizer 15deg 36mm x 17mm
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613053871·Mandel Nucleus Manipulator/Rotator, Titanium, V...
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575183432·Proximal tibial spacer, uncemented, Ti6Al4V, fo...
DIGITAL FOREHEAD THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SPEE-DEE PATCH
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 28, 2024
18 G X 1.5 IN. BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 26, 2017
COMPLETE EASY-RUB
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code LPN·October 8, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 8, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 7, 2011
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
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024