FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
FYC
2022-04-13
MHX
2022-04-13
CARESCAPE B450, E-musb
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LZA
2022-04-13
Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
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OLO
2022-04-13
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
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DZE
2022-04-13
ZENEX Implant System
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KCT
2022-04-13
Neodent Implant System-Helix NGM Compact Surgical Kit Cases
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KPI
2022-04-13
Keffort (MC-100, MC-100A)
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MAV
2022-04-13
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
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GEX
2022-04-12
LED Therapy Device (Planar LED/Planar LED mini)
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LHQ
2022-04-12
ThermPix Thermovisual Camera
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MHX
2022-04-12
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
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LZO
2022-04-12
Amis K Long
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