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
Digital Flat Panel Detector
Ray Imaging Technology (Haining) Limited
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
Depuy Ireland UC
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
Medtronic, Inc.
T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
Stryker GmbH
Single Use Bipolar Forceps
Hg Innovations, Ltd.
OsteoCentric ACL Fixation System
OsteoCentric Technologies
CMORE® CT System; CMORE® CT System Navigated Instruments
Icotec AG
Fine Osteotomy
Bodycad Laboratories, Inc.
Next Generation Access Catheter
Balt USA, LLC
NB 1 SA Implant System
Arum Dentistry Co., Ltd.
SIGMA Spectrum Infusion Pump with Master Drug Library
Baxter Healthcare Corporation
Disposable Endoscope Valve Sets
Sml Med-Tech Solutions Limited
Aspiron S ACP System
U&I Corporation
ASEPT® Glide Peritoneal Drainage System
Pfm Medical, Inc.
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System
Zsfab
Medical Protective Masks
Qinhuangdao Taizhi Medical Technology Co., Ltd.
BriefCase-Triage
Aidoc Medical , Ltd.
Kneevoice Cartilage Evaluation System (750-3600-001)
Kneevoice, Inc.
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
Guangdong Ace-Tec Co., Ltd.
SBC1 Cream
Sioxmed, LLC
Pectus Support Bar System
Biomet Microfixation
Wearable Electric Breast Pump (YM-8803)
Guangdong Youmeng Electrical Technology Co., Ltd.
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
Limacorporate
Biobeat Platform, BB-613WP Patch
Biobeat Technologies , Ltd.
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
Gigaalaser Company , Ltd.
PGDx elio plasma focus Dx
Personal Genome Diagnostics, Inc.
ProtekDilate Vascular Access Kit
Sorin Group Italia S.R.L.
ASUS Ultrasound Imaging System (LU800 series)
Asustek Computer, Inc.
Easycess Aspiration Pump
Guangzhou Easycess Medical Co.,Ltd
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