23 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sensor Medical Single Use Tonometer Prism
FDA 510(k)
FDA Class 2
·Ophthalmic
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756669795·POST-OP SHOE
CoRoent
FDA UDI
Nuvasive, Inc.·00887517566447·CoRoent Ant TLIF PEEK, 15x12x30mm 8°
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055103·
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036195281·
2.0 LactoSorb System
FDA UDI
BIOMET MICROFIXATION, INC·00888233025256·
SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS
FDA 510(k)
FDA Class 2
·Dental
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
UNKNOWN NGP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZP·April 10, 2025
PICOSURE WORKSTATION
FDA Adverse Event
Malfunction
·Product code GEX·October 3, 2014
PROTECTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
LACTO SCR 2.0X7MM 2.0 SYS 2/PK
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HWC·December 31, 2024
L SHAPE PLATE RIGHT EXTENDED
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·November 7, 2023
2.5X7MM LACTOSORB SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·November 7, 2023
2.0 X 7 MM LACTOSORB SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·November 7, 2023
L SHAPE PLATE LEFT EXTENDED
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·November 7, 2023
LACTO SCR 2.0X7MM 2.0 SYS 1PK
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·November 7, 2023
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013