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
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
Synovis Life Technologies. Inc. (A Subsidiary of Baxter
Fast Warm - NX
Fujifilm Irvine Scientific
Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants
Acuitive Technologies, Inc.
True Definition DL
Ge Healthcare Japan Corporation
SUREcore Prime Biopsy Instrument
Uro-1 Medical, Inc.
Préime DermaFacial Collagen+
EMA Aesthetics , Ltd.
CLAROX
Vsi Co., Ltd.
Mercury® II Spinal System
Spinal Elements, Inc.
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Jiangxi Maidikang Medical Devices Co., Ltd.
ClearPoint Array System (version 1.1)
ClearPoint Neuro, Inc.
Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, wi
Smith & Nephew, Inc.
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
Edwards Lifesciences, LLC
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
Jiangxi AOV Maternity & Baby Products Co., Ltd.
Hura CTP v1.0
Hura Imaging, Inc.
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech wi
Medline Industries, LP
Somfit D
Compumedics Limited
KARL STORZ Mediastinoscopes and Instruments
Karl Storz SE & CO. KG
MiniMed Go App
Medtronic Minimed
MSFX MIKRON SPINAL FIXATION SYSTEM
Mikron Makina Sanayi VE Ticaret Ltd. Sti.
Independent Corneal Viewing Chamber (IVC-21)
Bausch + Lomb, Incorporated
SABER-C System
Elevation Spine
SILO TFX MIS Sacroiliac Joint Fixation System
Aurora Spine, Inc.
FLOWRUNNER Aspiration System
Expanse Medical, Inc.
Moda-flx Hemodialysis System and Cartridge
Diality, Inc.
Bioabsorbable Anchor
Embody, Inc.
Vaginal Tactile Ultrasound Imager
Advanced Tactile Imaging, Inc.
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, L
Shenzhen Lescolton Electrical Appliance Co., Ltd.
CLARUS (700)
Carl Zeiss Meditec, Inc.
Disposable Nitrile Examination Gloves (Powder free, Blue)
Leping Shengde Medical Technology Company Limited
Angled Screwdriver MED (M-SD090)
W&H Dentalwerk Bürmoos GmbH
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