72 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VariAx 2 System
FDA 510(k)
FDA Class 2
·Orthopedic
COMPREHENSIVE REVERSE SHOULDER
FDA UDI
Biomet Orthopedics, LLC·00880304475533·
AZUR VACULAR PLUG
FDA UDI
Microvention, Inc.·00842429101612·AZUR VACULAR PLUG
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100936·JAFFE LID RETRACTOR LARGE
Lateral Patient Positioning System
FDA UDI
ALPHATEC SPINE, INC.·00190376471273·Paddle, Arm Support
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101025·JAEGER LID PLATE PLASTIC
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981027551·Straight Rod 5.5 x 500. The Coral Spinal System...
Stainless Steel
FDA UDI
Seaspine Orthopedics Corporation·10889981028268·Straight Rod, 500mm. The Stainless Steel Spinal...
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981121181·CoCr Str. Rod 5.5 x 500
PSL CLASSIC SLIT LAMP
FDA 510(k)
FDA Class 2
·Ophthalmic
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
FDA 510(k)
FDA Class 2
·Cardiovascular
Vasomedical-Biox™ Model 1805 Ambulatory Blood Pressure Recorder
FDA UDI
VASOMEDICAL, INC.·00817980020467·Model 1805 Ambulatory Blood Pressure Recorder
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·May 29, 2019
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 29, 2019
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·June 6, 2019
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·September 20, 2019
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 15, 2019
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code NDN·March 25, 2020
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 11, 2019
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·October 6, 2019