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
KLS Martin Drill-Free MMF Screw
KLS-Martin L.P.
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
Argon Medical Devices, Inc.
Balanced Knee System TriMax Porous Femoral Components
Ortho Development Corp.
ControlRad Select Model Z
Controlrad, Inc.
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
Tornier, Inc.
Taperloc® Complete Hip Stem
Biomet, Inc.
SOLIUS PRO UVB Light Panel
Solius Labs, Inc.
BioGend Interbody Fusion System 001 Cage
Biogend Therapeutics Co., Ltd.
Zipline Access Catheter
Perfuze, Ltd.
Disposable Manual Resuscitator
Xiamen Compower Medical Tech. Co., Ltd.
Powder Free Nitrile Examination Gloves, Blue Chemotest
Careglove Global Sdn. Bhd.
SPRINT PNS System
Spr Therapeutics, Inc.
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
Steris
Uterine ElevatOR PRO with OccludOR Balloon
The O R Company Pty, Ltd.
QT ECG
QT Medical, Inc.
Neo Sculptor (OF-NEO001)
Ofan Intelligent Technology (Guangzhou) Co. , Ltd.
eXaSkin Plus
Anatomical Geometry S.L.
HemosIL Silica Clotting Time
Instrumentation Laboratory (IL) Co.
FairFix AM Adjustable Button FairFix PSP Adjustable Button
Medacta International S.A.
Progenix Select Stim
Progenix, LLC
Fibresolve (with PCCP)
Imvaria, Inc.
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation
Electronic Thermometer (XHF2001, XHF2002)
Putian Hanjiang Huafeng Plastic Co., Ltd.
Surgical Face Mask (HNFM0103)
Shanghai Hua EN Industrial Co, Ltd.
ECHELON Oval V6.2 MRI System
Fujifilm Healthcare Corporation
Tristel Duo ULT
Tristel Solutions Limited
NightOwl
Ectosense NV
Origin Cemented Hip Stem
Signature Orthopaedics Pty, Ltd.
Arthrex SutureTape
Arthrex, Inc.
A-LYTE® Integrated Multisensor (IMT Na K Cl)
Siemens Healthcare Diagnostics, Inc.
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