FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
QSM
2025-03-11
OZT
2025-03-11
OutFlo Aortic Valve Dilatation Balloon Catheter
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OWQ
2025-03-10
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)
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GAG
2025-03-10
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
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KPJ
2025-03-10
Wound Treatment System (VHT-200)
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MEH
2025-03-10
Alteon® HA Femoral Stems
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JXG
2025-03-10
Duet External Drainage and Monitoring System (EDMS)
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KWT
2025-03-10
AGILON® XO Shoulder Replacement System
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BTA
2025-03-07
ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
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POS
2025-03-07
EpiWatch Monitoring System
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NPM
2025-03-07
Geistlich Bio-Flow®
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FBN
2025-03-07
Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
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