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
GMReis Suture Anchors
GM Dos Reis Industria e Comercio Ltda.
Medical Surgery Mask, Model:2626-7
Dongguan Missadola Technology Co., Ltd.
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV A
Yung Sheng Optical Co., Ltd.
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY
Noras Mri Products GmbH
DailyMate Orthodontic Aligner System
3D Global Biotech, Inc.
Belun Ring BLR-200 (BLR-200)
Belun Technology Company Limited
SOMAVAC® 100 Sustained Vacuum System
Somavac Medical Solutions, Inc.
SpaceFix Shoulder Spacer
G21, S.R.L.
CapnoSpot Pneumothorax Decompression Indicator
Pneumeric, Inc.
ALGO 7i
Path Medical GmbH
Customize
3D-Side S.A.
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
Owens & Minor (O&M) Halyard, Inc.
Oral Surgery Contra
Nakanishi, Inc.
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
Stryker
Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnosti
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Arthrex Virtual Implant Positioning (VIP) System
Arthrex, Inc.
PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
Stryker GmbH
Encore Hip Stem
Signature Orthopaedics Pty, Ltd.
TOPA12 Portable X-ray Unit
Neuf, Inc.
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
Biofire Diagnostics, LLC
EpiMonitor
Empatica S.r.l.
Brainomix 360 e-CTP
Brainomix Limited
Sensis Vibe (VD15)
Siemens Medical Solutions USA, Inc.
AI4CMR v2.0
Ai4medimaging Medical Solutions S.A.
Prospera Spectruum Negative Pressure Wound Therapy System
Deroyal Industries, Inc.
DASI Dimensions (V1.0)
Dasi Simulations
Eminent Spine 3D Lumbar Interbody Fusion Systems
Eminent Spine, LLC
Butterfly iQ3 Ultrasound System
Butterfly Network, Inc.
Electric Wheelchair (S500-6)
Zhongshan Sulenz Intelligent Technology Co., Ltd.
Koios DS
Koios Medical, Inc.
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