24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
FDA 510(k)
FDA Class 2
·Radiology
Catheter and Glove Suction Kit
FDA UDI
C. R. Bard, Inc.·00801741050657·Catheter and Glove Suction Kit with Solution Co...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003544·Right Reconstruction Plate w/Angle
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981179632·Z-Rod, Dia. 6.0mm, Co-Cr, 60mm
BioCORE
FDA UDI
COLLAGEN MATRIX, INC.·00813954024752·Moldable Bioactive Graft, 32mm x 32mm
BioCORE
FDA UDI
COLLAGEN MATRIX, INC.·00813954024769·Moldable Bioactive Graft, 50mm x 20mm
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2025
PCA INFUSOR
FDA Adverse Event
Injury
·IVAC MEDICAL SYSTEMS·Product code MEA·December 5, 1996
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CLONMEL IRELAND·Product code LWP·October 3, 2014
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code IXR·May 29, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 25, 2011
COMP RVRS SHLDR GLNSP STD 36MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·March 23, 2017
EQUINOXE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·January 9, 2024
ARCOM XL 44-36 STD HMRL BRNG
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·November 30, 2016
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
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