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
Clicky Cross
Yomura Technologies, Inc.
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Biofire Diagnostics, LLC
Tamarin Blue PTCA RX Dilatation Catheter
Natec Medical , Ltd.
Insulin Syringes
Chirana T. Injecta
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
Shenzhen Fittop Health Technology Co., Ltd.
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.
CATALYSTEM Femoral Stems
Smith & Nephew, Inc.
da Vinci SP Firefly Imaging System
Intuitive Surgical, Inc.
Dynamis Pro Family
Fotona D.O.O.
Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
National Bridge Industrial (S.Z.) Co., Ltd.
Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
Stryker GmbH
PEEK Spinal Infusion Cage
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Perin Health System (PHD80060-2)
Perin Health Devices, LLC
FP3D
Keystone Industries
Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
Shenzhen Med-Link Electronics Tech Co., Ltd.
EXPLORER AIR® II
Surgvision GmbH
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
Chalice Medical , Ltd.
Xpert Hemorrhagic Fever
Cepheid
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekt
Elekta Solutions AB
Surgical Gown (40083)
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
Siyang Threeguard Medical Supplies Co., Ltd.
DVT Motion Pneumatic Compression Device
Koge Micro Tech Co., Ltd.
IntelliSep test
Cytovale, Inc.
Extension Set
Medcaptain Life Science Co., Ltd.
End Cap
Medical Components Inc (Medcomp)
Progenix Select Stim
Progenix, LLC
Neodent Implant System - Helix Short Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Freedom Wrist Arthroplasty System
Ascension Orthopedics, Inc.
LMNT O2
Xplr , Ltd.
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