48 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LightLas Pattern Scanning System - TruScan Pro
FDA 510(k)
FDA Class 2
·Ophthalmic
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042120·4 Bicuspid Extraction
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASCENSION MODULAR TOTAL SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 12, 2023
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2020
INSPIRE 8F M
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 3, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·July 29, 2011
DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR
FDA Adverse Event
Malfunction
·Product code GEH·June 21, 2013
INSPIRE 8F M
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE OXYGENATOR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·December 11, 2025
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 20, 2021
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 11, 2020
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·December 23, 2020
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·July 24, 2025