FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
LPH
2022-03-09
FMF
2022-03-09
BD Insulin Syringe (0.3mL)
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NUH
2022-03-08
TENS & EMS DEVICE (Model: FM-B2403A)
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KTI
2022-03-08
Elation Pulmonary Balloon Dilation Catheter
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EZD
2022-03-08
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
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LFL
2022-03-08
Oclet TDS 1000
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NKB
2022-03-08
EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
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DQA
2022-03-08
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2
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NLF
2022-03-08
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)
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FXX
2022-03-08
Medical Face Mask
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ONF
2022-03-08
IPL Hair Removal Device
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JAK
2022-03-07
syngo.CT Applications
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