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
EVOS Patella Plates
Smith & Nephew
Private Stock Labs Surgical Face Mask
J.K. Private Stock, Inc.
Fogarty Occlusion Catheter
Edwards Lifesciences, LLC
NeoGen PSR System
Energist Limited
Audion ET dilation system
Entellus Medical, Inc.
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
Bozhou Rongjian Medical Appliance Co., Ltd.
Intimate Rose Vaginal Dilators
Plus EV Holdings Dba Intimate Rose
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
INTEROJO, Inc.
Powder Free Nitrile Patient Examination Gloves, Blue Color
Shandong Shangwei Medical Products Co., Ltd.
CADDIE
Odin Medical Limited
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
Maine Molecular Quality Controls, Inc.
Indigo® Aspiration System Aspiration Catheter 6X
Penumbra, Inc.
qXR-Detect
Qure.Ai Technologies
Wireless EEG System
Pascall Systems, Inc.
Surgical Mask
Tianchang Kanghui Protective Products Co, Ltd.
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
Primary Relief
Dyansys, Inc.
Flexible Block
Shandong Huge Dental Material Corporation
EZYPRO ECG Recorder (Model: UG02)
Sigknow Biomedical Co., Ltd.
EGIS Biliary Double Bare Stent (BDB080405)
S&G Biotech, Inc.
Flow-Nail
Flow-Fx, LLC
Bloomlife MFM-Pro
Bloom Technologies NV
Quantib Prostate
Quantib B.V.
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
Canon, Inc.
The Acumed Wrist Fixation System
Acumed, LLC
Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Materialise NV
ART-PLAN
Therapanacea
TiLink-P SI Joint Fusion System
SurGenTec, LLC
Resonic Rapid Acoustic Pulse Device
Zeltiq Aesthetics, Inc.
VisionAir Enhanced Stock Stent
VisionAir Solutions
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