13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PANAVIA F
FDA 510(k)
FDA Class 2
·Dental
Dakewe
FDA UDI
Shenzhen Dakewe Bio-engineering Co., Ltd·06973471960613·3 mL of Inactivated Transport Medium in screw-c...
Masel
FDA UDI
Ortho Organizers, Inc.·00190707035365·.016 X .022 Upper Elastinol™ Drift-Free Natural...
EkoSonic Endovascular Device with Control Unit 4.0
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTHRO-TRAC(TM)
FDA 510(k)
FDA Class 2
·Orthopedic
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023
POLARIS 5.5 / BALLISTA SPINAL SYSTEM IMPLANTS & INSTRUMENTS
FDA Adverse Event
Malfunction
·EBI, LLC.·Product code HXX·February 28, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 4, 2011
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·July 7, 2014
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024