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King LTSD Size 0,1 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

King LTSD Airway Kit (King Systems) – Pediatric Use Limitation (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

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King LTSD Size 0,1 (King Systems) – Pediatric Use Risk (2024)

King LTSD Airway Kit (King Systems) – Pediatric Use Limitation (2024)

Duraform Dural Graft Implant (Integra) – Endotoxin Levels (2024)

King LTSD Size 2.5 (King Systems) – Pediatric Use Risk (2024)

Elekta Biopsy Needle Kit (Elekta) – Microscopic Debris (2024)

Coated VICRYL Suture (Ethicon) – Needle Pull-Off (2024)

Monoject Insulin Syringe (Cardinal Health) – Incompatibility Risk (2024)

intelliPATH HRP Detection Kit (Biocare) – Weak Staining (2024)

Medex TranStar DPT Stopcocks (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Single 84in Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Kids 34in Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Kids 19in Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar 84in Single Set (Smiths Medical) – Pressure Monitoring (2024)

Medex Arterial Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Double Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar DPT Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Single 60in Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Transducer (Smiths Medical) – Pressure Monitoring (2024)

Medex NICU Monitoring Kit (Smiths Medical) – Pressure Monitoring (2024)

Quest Spectrum 3 System (Olympus) – EMC Compliance (2024)