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
Copioumed AAMI 3 Surgical Gown
Copioumed International, Inc.
Flow Water-Based Personal Lubricant
LBDO Group, Inc.
Venus Nova (FP-2001)
Venus Concept, Inc.
Sonic DL
Ge Medical Systems, LLC
CarboClear® Pedicle Screw System
CarboFix Orthopedics , Ltd.
Surgical Mask (sterile)
Nanjing 3h Medical Products Co., Ltd.
3D Anatomic Model
Ricoh USA, Inc.
Apollo TMS Therapy System
Mag & More GmbH
SURGIVISIO Device
Ecential Robotics
Glidewell TuffSplint Appliance Resin
Prismatik Dentalcraft, Inc.
MICRO Arterial Filters
Sorin Group Italia S.R.L.
ONVOY Acetabular System
Globus Medical, Inc.
Pre-Formed Blue
Lake Region Medical
Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
Orthalign, Inc.
Coloring Liquid
Dongguan Xiangtong Co., Ltd.
Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc.
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
Thermasolutions, LLC
AVIEW RT ACS
Coreline Soft Co., Ltd.
Falco Fusion System
Mcnicoll Surgical, Inc.
Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008);
Shenzhen Desida Technology Co., Ltd.
Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
Prevest Denpro Limited
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U10
Unimed Medical Supplies, Inc.
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
Esaote, S.p.A.
Personalized Therapy Comfort Settings (PTCS)
Resmed Corp
Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)
Palodex Group OY
MEMO Patch M (MPT-E08R-UNC01)
Huinno Co., Ltd.
Neodent Implant System - GM Narrow Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
c-med0 alpha
Cosinuss GmbH
InferOperate Suite
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry
Rb Health (Us)
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