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
Kubtec Mozart (XPERT42)
Kub Technologies, Inc.
MSC SFM
Yocon Biology Technology Company
Tornier Perform Advanced Glenoid
Tornier, Inc.
120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000)
Stryker Instruments
COLONNADE Posterior Screw Fixation System
CG Bio Co., Ltd.
Linkt Compression Staple System
Trax Surgical
Electric wheelchair (NSDS-01)
Hebei Dansong Medical Technology Co., Ltd.
Akunah REFLECT
Akunah Pty, Ltd.
NeatNick Heel Safety Lancet
Facet Technologies, LLC
Tina-quant Lipoprotein(a) Gen.2 Molarity
Roche Diagnostics Operations
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equ
Physio-Control, Inc.
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
Medcad
VueJect® Ultrasound Enhancing Agent Delivery System
ACIST Medical Systems, Inc.
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
Edwards Lifesciences, LLC
EasyTouch Lancing Device
Stat Medical Devices
HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
O&M Halyard, Inc.
LOQTEQ® VA Elbow Plates 2.7/3.5 System
Aap Implantate AG
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201,
Wenzhou Xikang Medical Instruments Co., Ltd.
Dentsply Sirona Titanium Bases system
Dentsply Sirona
UniPearls® Embolic Microspheres
Suzhou Haowei Medical Technology Co., Ltd.
BioClean Implant Restorative System
Bioclean Dental, LLC
CCI PACS VIEWER (PACS-US-001)
CliniComp, Intl.
WaveSense Jazz Blood Glucose Monitoring System
Agamatrix
Safe Secure Sterilization Pouches and Rolls
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)
Palodex Group OY
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
Quanta System Spa
Powder Free Nitrile Patient Examination Gloves, Blue Color
Shandong Shangwei Medical Products Co., Ltd.
Emerge Monorail PTCA Dilatation Catheter
Boston Scientific
LOGIQ P10, LOGIQ P9, LOGIQ P8
GE Medical Systems Ultrasound and Primary Care Diagnostics
FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix B
Prosidyan, Inc.
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