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
EASYMAX Tag Self-Monitoring Blood Glucose System
Eps Bio Technology Corp.
3D-RD-S
Radiopharmaceutical Imaging and Dosimetry, LLC
DSM Biomedical Calcium Phosphate Cement
Dsm Biomedical
Microcatheter
Surmodics,Inc.
RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System
MiRus, LLC
LED Curing Light (C01-X, C02-X)
Premium Plus (Dongguan) Limited
Wearable Breast Pump (Model S21A)
Shenzhen TPH Technology Co., Ltd.
Sectra Digital Pathology Module (Version 3.3)
Sectra AB
PressON Spinal Fixation System
Nexus Spine
BIOFIRE FILMARRAY Tropical Fever Panel
Biofire Diagnostics, LLC (Biomerieux)
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135
Fort Defiance Industries, LLC
RadiForce MX317W
Eizo Corporation
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-
bioMerieux, Inc.
Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)
Innova Vascular, Inc.
Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant
Prismatik Dentalcraft, Inc.
KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
Cytocell Limited
Inessa System
Triple Jump Israel , Ltd.
Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
Davol, Inc.
IPL400
El Global Trade, Ltd.
SPY Laparoscope
Stryker Endoscopy
SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
Si-Technology, LLC
Emily's Care Nourish Test System (Model 1)
Lactation Lab, Inc.
dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
Philips Medical Systems Nederland B.V.
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
Exactech, Inc.
Instrument Case P1340904
Cochlear
Materialise TKA Guide System
Materialise NV
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356,
Alicn Medical Shenzhen, Inc.
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
Zhejiang Carebao Co., Ltd.
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
Nxstage Medical, Inc.
Sterile Hypodermic Needles for Single Use
Azur Medical Company, Inc.
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