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
VitreJect Syringe
Ocuject, LLC
Community Containers (Flap and Daisy)
Keter Canada, Inc.
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
Kronus, Inc.
APOLLO ADVANTAGE Nitrile Examination Gloves
Dell Corning Corporation
Soundly Anti Snoring Device
Greystone Ip, Ltd.
Sterile Auto-Disable Syringes with/without Needle for Single Use
Wepon Medical Technology Co., Ltd.
RADx Intraoral Appliance for Snoring and Sleep Apnea
Achaemenid, LLC
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
Siemens Healthcare Diagnostics, Inc.
Injectable Root Canal Sealer (KP-Root SP)
Guilin Kevin Peter Technology Co., Ltd.
Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Perfuze, Ltd.
Celsi Monitor
Hadleigh Health Technologies
Kerecis Parvus (50207)
Kerecis Limited
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
Pausch Medical GmbH
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
Roche Molecular Systems, Inc.
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM T
Inomed Medizintechnik GmbH
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited
HBL Blade Assembly
Hand Biomechanics Lab, Inc.
Integrated Endo System (Meet Endo-II)
Denjoy Dental Co., Ltd.
Lancing device
SteriLance Medical (Suzhou), Inc.
United Orthopedic Knee Patient Specific Instrumentation
Enhatch, Inc.
LuxCreo Flexible Partial Denture Resin
LuxCreo, Inc.
Straight Arm DDR
Konica Minolta Healthcare Americas, Inc.
Viz RV/LV
Viz. Ai, Inc.
Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multic
Techno-Path Manufacturing , Ltd.
Back 3 COLOR
Swims America Corp
DePuy Synthes VOLT Proximal Tibia 3.5 Plating System
Synthes GmbH
cobas liat CT/NG nucleic acid test
Roche Molecular Systems, Inc.
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Inte
Qura S.R.L
Adin Long Dental Implant System
Adin Dental Implant Systems , Ltd.
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
Hlb Lifescience Co., Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert