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
HotDog Warming Mattress + Return Electrode
Augustine Temperature Management, LLC
OW100S
Softwave/Trt, LLC
Golden Isles Pedicle Screw System
Intelivation, LLC
3D-SHAPER
3D-Shaper Medical S.L
TearRepair Liquid Skin Protectant
Optmed, Inc.
OsteoProbe (OP-100)
Active Life Scientific, Inc.
BioSonic US200 Ultrasonic Scaler (60034537)
Dent4you AG
Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene®
Terragene S.A.
ExactechGPS® Total Ankle Application
Blue Ortho
Southern Anterior Screw Fixated Cage (SASCA)
Southern Medical (Pty) , Ltd.
QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
Dehas Medical Systems GmbH
Disposable Medical Nitrile Examination Gloves
Jiangsu Maolin Medical Technology Co., Ltd.
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ort
Stryker Leibinger GmbH & Co KG
Stem Extension Line (USTAR II System)
United Orthopedic Corporation
Powder Free Nitrile Examination Gloves (White, Blue and Black)
Alcatron Gloves Factory
QIAstat-Dx GI Panel 2 Mini B&V
QIAGEN GmbH
iSyncWave
iMediSync, Inc.
Active System; Avenue8
Caerus Corporation
Medline Smoke Evacuation Shroud
Medline Industries, Inc.
Wireless Probe Type Ultrasound Scanner
Xuzhou Yongkang Electronic Science Technology Co., Ltd.
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
New York Embroidery Studio (NYES)
EzVu Visual Vasopressor injector (EV-19)
Veol Medical Technologies Pvt , Ltd.
Salvo® Spine System
Spine Wave, Inc.
Insignia Anterior Cervical Plate System
Alphatec Spine, Inc.
Omnia Medical Coupler-C Anterior Cervical Plate
Omnia Medical, LLC
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
Merit Medical Pte. , Ltd.
DLP Silicone Coronary Artery Ostial Cannulae
Medtronic, Inc.
HKT Anatomical Locking Trauma System
Hankil Tech Medical Co., Ltd.
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
F Care Systems USA, LLC
Invisalign System
Align Technology, Inc.
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