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Browse 341 FDA-cleared medical devices

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341 devices

CERABIEN MiLai (K250673)

Class Class II K250673 EIH
2025-05-29

CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) (K250452)

Class Class II K250452 FED
2025-06-02

Clave™ Neutral-Displacement Needlefree Connectors (K250616)

Class Class II K250616 FPA
2025-06-05

Central Station (K242750)

Class Class II K242750 MSX
2025-06-05

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K251452)

Class Class II K251452 FRC
2025-06-06

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (K250891)

Class Class II K250891 FCM
2025-06-06

Cirrus Resting State fMRI Software (K251009)

Class Class II K251009 QIH
2025-06-06

CO2 Laser Machine (Lume) (K250465)

Class Class II K250465 GEX
2025-06-09

COAPTIUM Connect with TISSIUM LIGHT (DEN240066)

Class Class II DEN240066 SFD
2025-06-17

CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (K251017)

Class Class II K251017 OAP
2025-06-17
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