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
Smart Neck Stimulator
Guandong Skg Intelligent Technology Co., Ltd.
EMPHASYS Acetabular System
Depuy Ireland UC
Theia NPWT Foam Wound Dressing Kit
Clear Choice Therapeutics, Inc.
Livi Device
Liviwell, Inc.
Medical Surgical Mask
Hunan Zhenheyikang Medical Instrument Co., Ltd.
Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
ABBOTT MEDICAL
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elit
Boston Scientific Corporation
ExacTrac Dynamic
Brainlab AG
Annalise Enterprise CXR Triage Trauma
Annalise-Ai Pty , Ltd.
Pocket III
Quantel Medical
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
W.A. Rubbermate Co., Ltd.
Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode
Momentis Surgical , Ltd.
StimTrial Neuromodulation System
Bioventus, LLC
i-STAT hs-TnI cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Wolff's Law Anterior Cervical Plate System
Spinal Simplicity, LLC
Wrist Blood Pressure Monitor (BPM-W1VL)
Shenzhen Imdk Medical Technology Co., Ltd.
RODIN Expandable Lumbar Cage System
Ctl Medical Corporation
EzOrtho
Ewoosoft Co., Ltd.
Real Intelligence CORI
Blue Belt Technologies, Inc.
EXULT Knee Replacement System
Corentec Co., Ltd.
Bodygard SFS Surgical Gown Level 3
Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi
INNO SLA Submerged Narrow Implant System
Cowellmedi Co., Ltd.
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXS
DRTECH Corporation
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
Tuttnauer , Ltd.
Electrically Powered Wheelchair
Kunshan Hi-Fortune Health Products Co., Ltd.
CUBE Air Purifier
Samsung Electronics Co., Ltd.
Elevo Snoring Intervention Set
Zelegent, Inc.
APEX 3D Total Ankle Replacement System
Paragon 28, Inc.
Cold/Hot Compression
Jkh Health Co., Ltd.
Fogarty Fortis Arterial Embolectomy Catheter
Edwards Lifesciences
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