FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
BSP
2024-09-11
LZA
2024-09-11
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
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BZQ
2024-09-11
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
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IYN
2024-09-11
Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging
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JWH
2024-09-11
Rx Knee System
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EBF
2024-09-11
C&B NFH Hybrid
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QEW
2024-09-11
Pounce XL Thrombectomy System (PTS-1011-7F135)
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IYN
2024-09-11
FETOLY-HEART
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MAX
2024-09-11
Signus Tetris™ St; Signus Tetris™ R St
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MAI
2024-09-11
HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
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HGX
2024-09-11
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
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OWQ
2024-09-10
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
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