14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
FDA 510(k)
FDA Class 2
·Cardiovascular
Embla
FDA UDI
S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD·07290013817044·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003674·Medium 8 Hole BSSO Plate
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319740255·Crafoord (Coller) Artery Forceps 9-1/2" (24.1cm...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694047692·Medium 8 Hole BSSO Plate, Sterile
OsteoMed
FDA UDI
OSTEOMED LLC·00845694064439·2.0 System 8 Hole Medium BSSO Plate Sterile Qty 2
AMEDITECH IMMU TEST DRUG SCREEN PANEL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CORVUS RADIATION THERAPY PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2024
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA·Product code BSZ·May 29, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 25, 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