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
BELLUS-Q
Speclipse, Inc.
INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
Siemens Healthcare Diagnostics Products GmbH
iGPS Navigation Instruments
SI-BONE, Inc.
Magnetic Surgical System
Levita Magnetics International Corp
CapnoSpot Pneumothorax Decompression Indicator
Pneumeric, Inc.
Urethral Warming Catheter Kit
Varian Medical Systems, Inc.
GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
Vascular Solutions, LLC
Montage Flowable Settable, Resorbable Bone Paste
Orthocon, Inc.
CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor
Verathon Medical (Canada) Ulc
Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
Shanghai AnQing Medical Instrument Co., Ltd.
BioPoly Radial Head Implant
BioPoly, LLC
RCT600
Ray Co., Ltd.
Core Metabolic
Truvian Health
MD.ai Viewer
Mdai, Inc.
PrimmaArt
Dentscare Ltda
IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoT
Alphatec Spine, Inc.
Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Re
Covidien, LLC
TumorSight Viz
SimBioSys, Inc.
EO Chex Indicator Tape
Propper Manufacturing Co., Inc.
Airmod
Heroic Faith International , Ltd.
STA- NeoPTimal
Diagnostica Stago S.A.S
Rotarex Atherectomy System
C.R. Bard, Inc.
Eve Patient Positioner System
Leo Cancer Care
Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
Applied Medical Resources Corporation
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
SprintRay Denture Base
Sprintray, Inc.
Evolve Nitric Oxide Delivery System
Mallinckrodt Manufacturing, LLC
Osteon Precision Milled Suprastructure
Implant Solutions Pty Ltd (Aka Osteon Medical)
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
Coloplast
Excelsior System
Blue Ocean Global
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