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 Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
Guangzhou Pinzhi Medical Technology Co., Ltd.
Disposable Infusion Bag for Parenteral Nutrition
Beijing L&Z Medical Technology Development Co., Ltd.
Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipola
Dornier Medtech America Inc (Dmta)
Disposable Medical Masks
Hantech Medical Device Co., Ltd.
Versius Surgical System (Versius Plus)
Cmr Surgical Limited
Surgical Sutures with or without Needle
Huaian Seamen Medical Technology Co., Ltd.
VersaPump Infusion System
Emed Technologies Corporation
SleepRes PAP System
Sleepres, Inc.
MateLaser Medical Diode Laser Systems (ML-DLS-30)
Matelaser, Inc.
Safety Lancet
Ningbo Medsun Medical Co., Ltd.
Rapid Platform (R6.7)
Ischemaview, Inc.
Verruca-Freeze H
Cryosurgery, Inc.
Assure Titanium Blood Glucose Monitoring System
Arkray, Inc.
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
Shen Zhen Cambridge-Hit Co., Ltd.
Dental Barriers and Sleeves (AB0006)
ANI Co., Ltd.
STAR RF Ablation System
Merit Medical Systems, Inc.
Powder Free Vinyl Examination Gloves
Shanghai Shengda Medical Applications Co., Ltd.
FloPatch FP120
Flosonics Medical
Spectra Platinum Mini
Uzinmedicare Co., Ltd.
Simparo Anchor Line Fixation System
Simparo, Inc.
Xpert Respiratory Panel
Cepheid
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10
Ethicon Endo Surgery, LLC
Hyper Insight - ICH
Sk, Inc.
Orthex External Fixation System
OrthoPediatrics Corp.
BTL-785MJ
BTL Industries, Inc.
TOV Dental Implant System
Rdj Tov Implant, Ltd.
ARENA Star, Galaxy Star
Arum Dentistry Co., Ltd.
Porous Patella
Encore Medical, L.P. Dba Djo Surgical
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
Edwards Lifesciences, LLC
BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
Vivachek Biotech (Hangzhou) Co., Ltd.
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