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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