10 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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MIROCAM CAPSULE ENDOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ForPro
FDA UDI
Tng Worldwide, Inc.·00672047001274·Black Vinyl Exam Gloves
Size Medium
100ct
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
FDA 510(k)
FDA Class 2
·Neurology
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·October 3, 2014
EXPLOR IMPLANT LOCKING SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWI·May 31, 2013
SOF CARE INFLATOR ASSY
FDA Adverse Event
Malfunction
·STRYKER CORP DBA GAYMAR·Product code INX·June 15, 2011
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
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018