FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
OLO
2024-12-06
QAS
2024-12-06
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
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OHT
2024-12-06
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
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CAW
2024-12-06
Rugged Oxygen Generator (ROG) (RO01-00001)
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QQX
2024-12-06
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
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LHI
2024-12-06
SmartSiteTM Vented Vial Access Device
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PNG
2024-12-06
PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50-
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KLA
2024-12-06
RED
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PLF
2024-12-06
OsteoSinter® EVANS and COTTON wedges and related accessories
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KWS
2024-12-06
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
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LLZ
2024-12-06
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
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OAB
2024-12-06
NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)
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