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
Eminent Spine SI Screw System
Eminent Spine, LLC
Genie MAX Large Bore Introducer Sheath
Cultiv8 1, LLC
Hemastyl() Wound Dressing
Rapid Nexus Nanotech Wound Solutions, Inc.
CloudCath Peritoneal Dialysis Drain Set Monitoring System
Cloudcath
RI.HIP MODELER
Blue Belt Technologies, Inc.
Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20
Shenzhen Smallsignal Technology Co., Ltd.
PlazMagik
Agnes Medical Co., Ltd.
Cassette Autoclave (ACA5)
Guangzhou Ajax Medical Equipment Co., Ltd.
Transducer Probe Cover
Hony Medical Co., Ltd.
Zamenix P
Roen Surgical, Inc.
Compact Wearable Pump
Lansinoh Laboratories
ClearHemograsper
Finemedix Co., Ltd.
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Changsha Honchon Technology Co., Ltd.
CentriMag Pre-connected Pack
Abbott
MediLab
Sigma Scientific Services, LLC
G7, Dental Operative Unit and Accessories
Shinhung Company, Ltd.
Galen Second Read
Ibex Medical Analytics , Ltd.
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
Edwards Lifesciences, LLC
Firstar Dental Electric Motor
FDC Technology Industry Co.
EMBOGUARD Balloon Guide Catheter
Neuravi Limited
Glass Ceramic
Shenzhen Xiangtong Co., Ltd.
Firefighter Pro PTCA Balloon Catheter
Shanghai MicroPort Medical (Group) Co., Ltd.
DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System
Synthes GmbH
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
Zhejiang Gongdong Medical Technology Co., Ltd.
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
Telefield Medical Imaging (Shenzhen) Limited
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
Thermo Fisher Scientific
Fusion Craniofacial Implant; Fusion Skull Implant
Kelyniam Global, Inc.
Veritas Reverse Total Shoulder System
Restor3D
Safety lancet (XL)
Tianjin Huahong Technology Co., Ltd.
BioPoly Radial Head Implant
BioPoly, LLC
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