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
Non-sterile, Powder-Free Latex Examination Glove
Sri Trang Gloves (Thailand) Public Company Limited
Picosecond Nd:YAG Laser System; PICO LEGEND
Ami, Inc.
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
Mezorrison Medical Technology (Dongying) Co., Ltd.
Aspirex Thrombectomy System
C.R. Bard, Inc.
Parietene Macroporous Mesh (PPM5050 )
Sofradim Production
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Gm Dos Reis Industria E Comerico Ltda.
Heel Incision Safety Lancet
SteriLance Medical (Suzhou), Inc.
CELERITY HP Chemical Indicator
STERIS Corporation
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
Shanghai Caremate Medical Device Co., Ltd.
Polyfusion IV Administration Sets
Poly Medicure Limited
Scaida BrainCT-ICH (v1.0)
Mlhealth 360
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
Exactech, Inc.
Disposable Endoscopic Distal Attachments
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
Blue Sky Bio, LLC
ROSA Hip System
Orthosoft D/B/A Zimmer Cas
RefleXion Medical Radiotherapy System (RMRS)
Reflexion Medical, Inc.
Veloxion System
Corinth Medtech, Inc.
Stryker Resorbable Fixation System
Stryker Leibinger GmbH & Co KG
Nanox.ARC
Nano-X Imaging , Ltd.
STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette
Plasmapp Co,., Ltd.
StealthStation S8 Spine Software
Medtronic Navigation, Inc.
Access AMH
Beckman Coulter, Inc.
EndoCore
Praxis Medical, LLC
VERTICALE® Navigation Instruments
Silony Medical GmbH
Applanation Tonometer HT-5000
Huvitz Co., Ltd.
QuietLab Pro
QuietLab, LLC
TENS&EMS units (SM9109A, SM9109B)
Plexus Yoga, LLC Dba Chirp
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
Hearx SA (Pty) , Ltd.
Southern Implants Instrument Trays
Southern Implants (Pty), Ltd.
Minder System
Epi-Minder Pty, Ltd.
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