510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
3,400 total clearances
StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
Staclear, Inc.
Fusion FibFix Nail
Fusion Orthopedics USA, LLC
Heuron ICH
Heuron Co., Ltd.
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
Biofire Defense, LLC
da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
Disposable Prophy Angle
Pacific Care Limited
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
Sorin Group Italia S.R.L.
ENDOGATOR Hybrid Irrigation Tubing
Medivators
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
SPINEART Navigation Instrument System
Spineart SA
Knee+
Pixee Medical
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
Millennium Medical Technologies Inc (Dba Cellmyx)
Aveta System 2.0
Meditrina, Inc.
BruxZir® Radiant
Prismatik Dentalcraft, Inc.
reVive Light Therapy LED Cleansing System
Led Technologies, Inc.
Vitrification Solution Set and Warming Solution Set
Ecmpc, LLC
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTr
Stryker Spine
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
Lumenis Be, Ltd.
QOCA image Smart CXR Image Processing System
Quanta Computer, Inc.
Sonio Suspect
Sonio
Electric wheelchair (HC819N, HC830N, HC831N)
Yongkang Hengyi Vehicle Co., Ltd.
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
Coloplast Corp.
PosiSep EAR Fragmentable Ear Dressing
Hemostasis, LLC
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
3M Healthcare Business Group
Sparrow Ascent
Spark Biomedical, Inc.
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
Canon Medical Systems Corporation
ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
Siemens Medical Solutions USA, Inc.
Genesys Spine AIS-C II Cervical Interbody Fusion System
Genesys Spine
Cubresa BrainPET
Cubresa, Inc.
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