72 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SafeGuide®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021095·Esophageal Dilator, 33 French
MaxFuse VBR, 10 (D) x 12 (W) x 49 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055530·10 (D) x 12 (W) x 49 (H)
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
FDA 510(k)
FDA Class 2
·Radiology
DEPUY ATTUNE KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929064719·Corpectomy, 12Dx14Wx33H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929038826·Corpectomy, 12Dx14Wx33H 6°
BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 30, 2025
BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 30, 2025
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 3, 2017
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·February 2, 2016
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 27, 2016
FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 29, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·May 5, 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
EVOLUTION BILIARY CONTROLLED-RELEASE STENT-FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·March 25, 2015
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·April 24, 2015