RecallHawk

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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