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
Sensual Massage, Ultra Pure
Dreambrands, Inc.
Surgical Face Masks, Model: EFMDS-L50Pn BLU
Iris USA
Multitom Rax with True2scale Body Scan Option
Siemens Medical Solutions
Nuvola
Gruppo Europeo Ortodonzia Srl
Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc.
Safe Secure Sterilization Pouches and Rolls
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
Elexir
Nu Eyne Co., Ltd.
CuRAS hybrid
Classys, Inc.
SternaFuse Fixation System
Fusion Innovations, LLC
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
bioMerieux, Inc.
Polypectomy Snare
Hangzhou AGS MedTech Co., Ltd.
Bioptimal Bipolar Pacing Catheter
Bioptimal International Pte. , Ltd.
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Ortho-Clinical Diagnostics, Inc.
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
Rb Health (Us), LLC
ESSENZ Patient Monitor
Livanova Deutschland, GmbH
BonOs® Inject Bone Cement; NEO Pedicle Screw System
Neo Medical SA
Evita V800, Evita V600
Draegerwerk AG & CO Kgaa
Erchonia Zerona Z-Bed
Erchonia Corporation
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
Gbs Commonwealth Co., Ltd.
3DXR
GE Medical Systems SCS
Creo Electrosurgical System with NP1 Instrument
Creo Medical, Ltd.
EVA15 insufflator
Palliare , Ltd.
Stella
Shinhung Mst Co., Ltd.
i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
Providence Medical Technology, Inc.
CDI OneView Monitoring System
Terumo Cardiovascular Systems Corporation
Materialise TKA Guide System
Materialise NV
PRO-LITE Sterilization Tray
STERIS Corporation
Star E900 Handpiece Series
Dentalez, Inc., Stardental Division
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
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