FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
KRO
2025-08-22
DQY
2025-08-22
CPS Locator 3D Delivery Catheter
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DQK
2025-08-22
CARTO™ 3 EP Navigation System V8.1
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IZL
2025-08-22
PROMO
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EKX
2025-08-22
EnDrive (EnDriveUS)
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NRY
2025-08-22
CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set
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QIH
2025-08-22
MammoScreen BD
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FMF
2025-08-22
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec
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IYN
2025-08-22
Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)
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LON
2025-08-21
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
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FCG
2025-08-21
ClearTip FNA and FNB Types
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OHS
2025-08-21
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
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