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
Symani Surgical System
Medical Microinstruments, Inc.
Rapid LVO
Ischemaview, Inc.
Nitrile disposable examination gloves
Xingyu Medical Tech Co., Ltd.
Light Cure Composite
Sincera Technology (Changchun) Co., Ltd.
RipCord
TriMed, Inc.
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microte
Microtek Medical, LLC
NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner
SeaSpine Orthopedics Corporation
LiquID .051 LP Guide Catheter Extension
Seigla Medical, Inc.
Tisuthes e-PTFE Surgical Patch
Shanghai Suokang Medical Implants Co., Ltd.
ExactechGPS® System
Blue Ortho
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA
Brosmed Medical Co., Ltd.
Vertex Thrombectomy System
Jupiter Endovascular
CONDUIT Lateral Switch Plate
Medos International SARL
PicoStar
Asclepion Laser Technologies GmbH
EK Digital Abutments
Hiossen, Inc.
Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direc
Prismatik Dentalcraft, Inc.
10PL
Tentech Co. , Ltd.
Polyfusion IV Administration Sets
Poly Medicure Limited
SmartCT (R3.0 (L10))
Philips Medical Systems B.V.
Liverty TIPS Access Set
Bard Peripheral Vascular, Inc.
INNO SLA Submerged Hybrid Ti-Base System
Cowellmedi Co., Ltd.
ViSiGi 3D Gastric Sizing Tube
Boehringer Laboratories
Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
Zhejiang Curaway Medical Technology Co., Ltd.
IPL Hair Removal Device
Ulike Co., Ltd.
CRYOcheck Factor VIII Deficient Plasma with VWF
Precision Biologic, Inc.
Open Rib
Canon Medical Informatics, Inc.
Spinal System
Teslake, Inc.
CONNEQT PULSE
Atcor Medical
SYMPHONY OCT System
Medos International SARL
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
Shockwave Medical, Inc.
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