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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

Ion Endoluminal System (IF1000)

Intuitive Surgical, Inc.

DeepFoqus (DeepFoqus-Accelerate)

Foqus Technologies, Inc.

Spectricept Skin and Wound Cleanser

Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.

ECGenius System

Cath Vision Aps

TriVerity

Inflammatix, Inc.

Exablate Prostate System

Insightec, Inc.

Electrosurgical Pads

Baisheng Medical Co., Ltd.

S.I.N. Dental Implant System

S.I.N. – Sistema DE Implante Nacional S.A.

Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask

Sleepnet Corporation

Wishbone HA

Wishbone SA

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (

Alcon Laboratories, Inc.

Coolfase

Asterasys Co., Ltd.

Momcozy Wearable Breast Pump (BP223)

Shenzhen Root Innovation Technology Co., Ltd.

AV Viewer

Philips Medical Systems Nederland B.V.

MicroPen EVO

Eclipse Medcorp, LLC

BreathePal Bilevel (GFM50-MD2201)

Compal Electronics, Inc.

Circul8 Pro

Ortho8, Inc.

Alpha Vent PEEK Suture Anchor

Stryker Endoscopy

PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup

Aicheck Biotech, Inc.

Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31

Cardinal Health200, LLC

BTL-754FF

BTL Industries, Inc.

AdvaTx

Advalight Aps

Signature™ ONE System

Orthosoft Inc. (D/B/A) Zimmer Cas)

Electric wheelchair (N3901)

Zhejiang Richall Medical Technology Co., Ltd.

Delta III Pro

Dornier Medtech America, Inc.

MicroMatrix® Flex

Acell, Inc.

Sonosite MT Ultrasound System

FUJIFILM Sonosite, Inc.

Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)

Shenzhen Ulike Smart Electronics Co., Ltd.

IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)

Shenzhen Lescolton Electrical Appliance Co., Ltd.

Correx Software

Vilex, LLC

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