19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BODYGEM, MODEL HB211
FDA 510(k)
FDA Class 2
·Anesthesiology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105770·Zirlux Multi-Unit Abutment 3.5 mmH compatible w...
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033182079·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033182093·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033182116·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033182086·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105070·Draw Rod, Primal T- Handle
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033182130·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033182123·
YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA
FDA 510(k)
FDA Class 1
·Dental
OUTBACK CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
22G X1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 14, 2019
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 18, 2019
GRANULFO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE·Product code KPO·March 15, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 1, 2011
ATLAS + HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·March 10, 2008
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 2023
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021