28 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Thoracic VCAR with GSI Pulmonary Perfusion
FDA 510(k)
FDA Class 2
·Radiology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304438187·
FX V 135 stem
FDA UDI
FX SOLUTIONS·03701037315132·FX V 135 stem TA6V Ø32/10 cementless Ti/HA
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1
CORFLO ANTI IV ENTERAL FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2017
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 3, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·June 21, 2013
VANGUARD COMPLETE KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018
TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
VANGUARD COMPLETE KNEE SYSTEM TIBIA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
UNKNOWN PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
VANGUARD POSTERIOR STABILIZED TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 27, 2018
SERIES-A ASYMMETRIC PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 27, 2018
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 11, 2022
BIOMET CRUCIATE TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 27, 2018
ARCOM SERIES-A PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 23, 2017
BIOMET CC CRUCIATE TRAY 79MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 9, 2025