20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JPS JuniOrtho Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777587·LUMBAMED BASIC DORSAL STAY WM SILVER I
PROFYLE
FDA UDI
Stryker GmbH·07613153160045·Insertion Drill Guide
Depth gauge countersink
FDA UDI
Treace Medical Concepts, Inc.·00810111223416·Depth gauge countersink
7000 CONNECTORS
FDA UDI
HANS RUDOLPH, INC.·00817136022253·CONN 50.8OD X 28.6IDORG 7000
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319742495·Pennington Septum Elevator 8-1/4" (20.6cm), dou...
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159007589·SCANLAN® Aortic Aneurysm Clamp
Sonoma™
FDA UDI
Seaspine Orthopedics Corporation·10889981050863·Sonoma Anterior Cervical Plate 2 Level Plate, 46mm
RADIOCAMERAS EXTRACRANIAL SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
Manta Ray™
FDA UDI
Seaspine Orthopedics Corporation·10889981057138·Plate - 2 Level - 46 mm
MODULUS-STRUMENTO-ESTRATTORE
FDA Adverse Event
Malfunction
·LIMACORPORATE S.P.A.·Product code JDI·August 9, 2022
FEMORAL MODULAR HEAD - L Ø36MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·August 9, 2022
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·December 10, 2024
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 1, 2013
AXS VECTA 074 CATH 132CM - CE
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·June 7, 2024
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014