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
SmoothSkin Pure Adapt (SSG3)
Cyden Limited
Visualase V2 MRI-guided Laser Ablation System (9736422)
Medtronic Navigation
SkinPen Precision Elite System
Crown Aesthetics
Best Glove-Nitrile Powder Free Examination Glove
Bestsafe Glove Co., Ltd.
Doctor Tecar Plus, Doctor Tecar Smart
Mectronic Medicale S.R.L.
Atrial Fibrillation History Feature
Apple, Inc.
Selectra Lead Implantation System
Biotronik, Inc.
Single Use Cytology Brush
Zhejiang Chuangxiang Medical Technology Co., Ltd.
ViewFlex Eco Reprocessed ICE Catheter
ABBOTT MEDICAL
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
Atraverse Medical, Inc.
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
MULA (K2-A1)
Guangzhou Ciellulu Photoelectric Technology Co., Ltd.
Savvy Mask - Level 3 Surgical Face Mask
Texas Medplast, LLC
Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
Shinva Ande Healthcare Apparatus Co., Ltd.
AlphaVent Knotless SP PEEK Anchor
Stryker Endoscopy
Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
Shenzhen Root Innovation Technology Co., Ltd.
Hailie Sensor NF0109
Adherium (Nz), Ltd.
Cervical Spine Truss System (CSTS)
4Web Medical
Cobra Catheter System
Endovascular Engineering
Transpara 1.7.2
Screenpoint Medical B.V.
Syntec Orthodontic Mini Screw Extended System
Syntec Scientific Corporation
Fusion Robotic Navigation System
Alphatec Spine, Inc.
Disposable Blood Lancets
Huaian Hening Medical Instruments Co., Ltd.
RECLAIM Monobloc Revision Femoral Stem
Depuy Ireland UC
Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
Iridex Corporation
Savvy Surgical Mask - Level 3
Alg Health, LLC
EkoSonic Endovascular Device
Boston Scientific
F&P Optiflow Oxygen Kit (AA451J)
Fisher & Paykel Healthcare, Ltd.
InCore Subtalar System
Nextremity Solutions, Inc.
Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
Inion OY
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