359 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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EXPLOR RADIAL HEAD PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Humeris Shoulder
FDA UDI
FX SOLUTIONS·03701037306697·SYMETRIC GLENOID K-WIRE GUIDE + TEMPLATE SIZE XS
Matira
FDA UDI
Kalitec Direct LLC·B07307K1100010·Tray Insert 1, Matira, Arcamed
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037317693·HOLLOW GLENOID K-WIRE GUIDE + TEMPLATE SIZE XS
STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,
FDA 510(k)
FDA Class 2
·Dental
BAYER ADVIA IMS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011020100401·FEMORAL HEAD, 28MM DIAMETER, +4MM NECK
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011020100201·FEMORAL HEAD, 28MM DIAMETER, +0MM NECK
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011020101201·FEMORAL HEAD, 28MM DIAMETER, +12MM NECK
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011020100001·FEMORAL HEAD, 28MM DIAMETER, -4MM NECK
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011020100801·FEMORAL HEAD, 28MM DIAMETER, +8MM NECK
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 10, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 1, 2011
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 5, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 22, 2021
CENTURION VISION SYSTEM (ACTIVE SENTRY)
FDA Adverse Event
Injury
·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code HQC·July 11, 2024
NIM® 3.0 MAINFRAME
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·August 6, 2024
IMPELLA
FDA Adverse Event
Malfunction
·ABIOMED, INC. - 1220648·Product code OZD·April 15, 2026
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 18, 2022