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
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC
Edwards Lifesciences
Pelvic Muscle Trainer (KM510, KM516B)
Shenzhen Konmed Technology Co., Ltd.
GEN5 and GEN5+ 3.3mmD Dental Implants
Paragon Implant Mfg., LLC
G7® Revision Acetabular System
Zimmer, Inc.
TruDi Shaver Blade
Acclarent, Inc.
BIOMONITOR IIIm, BIOMONITOR III
Biotronik, Inc.
Defendo Single Use Cleaning Adapter for Olympus Endoscopes
STERIS Corporation
APS Spear Locking Plate
A Plus Biotechnology Co., Ltd.
uMR Astra
Shanghai United Imaging Healthcare Co., Ltd.
Lightning Viewer
Nexsys Electronics Inc. Dba Medweb
Bifurcated Needle
Anhui Tiankang Medical Technology Co., Ltd.
EndoLIF Delta-Cage and DoubleWedge-Cage
Joimax GmbH
OmniTaper EV Dental Implants, DS Implants abutments with EV connection
Dentsply Sirona
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
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software
Brainlab AG
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 Syste
Intuitive Surgical, Inc.
BD Alaris Pump Epidural Infusion Set
Care Fusion
MR Conditional Cup Electrodes
Technomed Europe
Forma Medical Headless Compression Screw
Forma Medical, Inc.
Stealth AXiS Surgical System with Stealth AXiS Spine clinical application
Medtronic Navigation, Inc.
Excipio SV Thrombectomy Device
Contego Medical, Inc.
Ion-C
SurGenTec, LLC
CardioChek Plus Test System; CardioChek Plus Home Test System
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
Sclerotherapy Needle
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Withings ECG App
Withings
AETOS Shoulder System Stemless Humeral Prosthesis
Smith & Nephew, Inc.
Baby Gorilla/Gorilla Plating System
Paragon 28, Inc.
Platform treatment system
Shanghai Apolo Medical Technology Co., Ltd.
Hakon, Hakon Smart
Medical San Indústria DE Equipamentos Médicos Ltda.
Hypertension Prediction Index (HePI) Algorithm
Edwards Lifesciences, LLC
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