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
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex
Medtronic Powered Surgical Solutions
APRO 55 Swift Catheter and Alembic Aspiration Tubing
Alembic, LLC
Surgical Gown
Wujiang Tutaike Textiles & Finishing Co., Ltd.
Iconic Nitrile Glove
Iconic Medicare Sdn Bhd
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrat
Ever Global (Vietnam) Enterprise Corporation
MCB UNIT Model: V10GMCBUS
Lamidey Noury Medical
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
Exactech, Inc.
NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Sin
AngioDynamics, Inc.
TopCEM-Veneer Light Cure Veneer Cement
Rizhao Huge Biomaterials Company, Ltd.
TargetCool (RM-DT02W)
Recensmedical, Inc.
Microcurrent Facial Device (CEC101, EE0101, EEI101)
Shenzhen Dachi Communication Co., Ltd.
DERMABOND PRINEO Skin Closure System
ETHICON, Inc.
Avanti Orthopaedics Ulnar Shortening System
Avanti Orthopaedics, Inc.
Body Temperature Software (BTS)
Fitbit, LLC
Albumin BCP2
Abbott Ireland Diagnostics Division
Samsung ECG App v 1.3 (ECG)
Samsung Electronics Co., Ltd.
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
Oriental Inspiration Limited
Arthrex Knotless FiberTak Suture Anchor
Arthrex, Inc.
SurfRider 13 Microcatheter
Kaneka Americas Holding, Inc.
MolecuLight I:X
MolecuLight, Inc.
TissueStat
Durastat, LLC
VIVIX-M
Vieworks Co., Ltd.
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
Nobel Biocare AB
BioSci Disposable Virus Sampling Tubes
Shenzhen Dakewe Bio-Engineering Co., Ltd.
Pitch PaSoft Tissue Reinforcement Device
Xiros, Ltd.
STELLAR Knee
Polarisar, Inc.
Medical electronic thermometer (FC01, FC02)
Zhuzhou Goldenhot Medical Technology Co., Ltd.
MetaLite DX Digital Pathology Software
Jellox Biotech, Inc.
THE Graft Collagen
Purgo Biologics, Inc.
Pediatric Nailing Platform Femur
OrthoPediatrics Corp.
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