17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GENERAL AND PLASTIC SURGERY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017743·K-Wire, Double Ended, Trocar Point, Diameter Si...
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901408352·20 BLADE FINISHING CARBIDE 8901 - 5 PACK
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAXZERO
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·March 17, 2026
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 3, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 31, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 31, 2011
BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023
BD MAXZERO¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013