510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
HippoMind (v1.0)
Hippoclinic
Spectral CT on Rails
Philips Medical Systems Nederland B.V.
Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbo
Mobarn Medical Devices, LLC
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
Shenzhen Urion Technology Co., Ltd.
UltraPrint-Dental Hard Splint UV
Guangzhou Heygears IMC., Inc.
Dermablate
Asclepion Laser Technologies GmbH
ClearCheck Model RADCC V2
Radformation, Inc.
NeuroTrac® MyoPlus Pro (MYO120U)
Verity Medical , Ltd.
Electronic Thermometer (XHF2001, XHF2002)
Putian Hanjiang Huafeng Plastic Co., Ltd.
SpO2 Extension Cable
Beijing Rongrui-Century Science & Technology Co., Ltd.
Cryo-Thermo Compression Device (FGK002)
Suzhou Microport Rehabtech (Group) Co., Ltd.
BruxZir NOW
Prismatik Dentalcraft, Inc.
Fiber Laser Treatment System
Shanghai Apolo Medical Technology Co., Ltd.
Neorad Pacs (Neorad Pacs)
Everrtech Software Pvt, Ltd.
Digital Color Doppler Ultrasound System (P60 Series)
Sonoscape Medical Corp.
Grandio disc multicolor
Voco GmbH
Mosie Baby Kit
Mosie Baby
Disposable Medical Mask
Yangzhou Runyi Arts & Crafts Co., Ltd.
Safety Lancet
Ningbo Medsun Medical Co., Ltd.
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Ultra Compression Screw System
Pace Surgical
Lotus Prophy Angle
Ajk Engineering, Inc.
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
Edwards Lifesciences
Alinity i STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Division
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
Cardio Flow Inc.,
Clearblue ® Early Pregnancy Test
Spd Swiss Precision Diagnostics GmbH
OptiMesh Multiplanar Expandable Interbody Fusion System
Spineology, Inc.
Stereotaxic Guiding Surgical Devices, NaoTrac S
Brain Navi Biotechnology Co., Ltd.
SDF Pro
Belport Company, Inc., Gingi-Pak
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test M
Assure Tech., LLC
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