Case Studies - FDA 510k
Walk through real 510(k) projects delivered by I3CGlobal, slide by slide. Select a device to see how it reached FDA clearance.
Polydioxanone Absorbable Surgical Suture
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- Product code
- NEW
- Project Tenure
- Feb 2024 – Jun 2025
Total Knee Replacement System
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- Product code
- JWH
- Project Tenure
- Jul 2024 – Sep 2025
Sterile Irrigation Solution
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- Product code
- FRO
- Project Tenure
- Jun 2024 – Aug 2025
Recirculating Air Cleaner
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- Product code
- FRF
- Project Tenure
- Sep 2022 – Dec 2024
Nitrile Examination Gloves
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- Product code
- LZA
- Project Tenure
- Sep 2022 – Dec 2024
Hypodermic Syringe
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- Product code
- FMF & FMI
- Project Tenure
- Aug 2023 – Dec 2024
Pedicle Screw System
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- Product code
- NKB
- Project Tenure
- Jun 2022 – Oct 2023
Pulse Sensor
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- Product code
- DRG – DSI – MHX
- Project Tenure
- Jun 2023 – Aug 2024
Polyglactin 910 Absorbable Suture
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- Product code
- GAM
- Project Tenure
- Jun 2024 – Aug 2025
Latex Male Condoms
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- Product code
- HIS
- Project Tenure
- Jul 2024 – Mar 2024
Medical Image Management and Processing System
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- Product code
- QIH + LLZ
- Project Tenure
- Jan 2023 – Dec 2023
Sterile Latex Surgical Gloves
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- Product code
- KGO
- Project Tenure
- Jun 2022 – Aug 2023
Non Sterile Surgical Face Mask
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- Product code
- FXX
- Project Tenure
- Mar 2023 – Aug 2024
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