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
MENTOR MemoryGel Enhance Single Use Gel Sizer
Mentor Worldwide, LLC
ARIX Rib System
Jeil Medical Corporation
TLX SRAs and TLX Gold Abutments
Institut Straumann AG
Elecsys CMV IgG
Roche Diagnostics
Carescape Canvas 1000; Carescape Canvas Smart Display
GE Healthcare Finland Oy
The Alma Soprano Titanium
Alma Lasers, Inc.
DermRays Revive
Wuhan Lotuxs Technology Co., Ltd.
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
Oticon Medical AB
BioCode Gastrointestinal Pathogen Panel (GPP)
Applied BioCode, Inc.
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
Avia Vascular
Neodent Implant System-Helix NGM Compact Surgical Kit Cases
JJGC Indústria e Comércio de Materiais Dentários S.A.
Spirair Nasal Septal Strap
Spirair, Inc.
PathLoc-TA Expandable Lumbar Cage System
L&K BIOMED Co., Ltd.
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
STERIS Corporation
The Cooral System
Braincool AB
Selectra Lead Implantation System
Biotronik, Inc.
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
MacroLux Medical Technology Co., Ltd.
Disposable Nitrile Examination gloves
Fujian Yuanxin Safety Protection Technology Co., Ltd.
SpaceOAR Flex System
Boston Scientific Corporation
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
Beckman Coulter, Inc.
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
Lucens Technology Co., Ltd.
NeVa PV Thrombectomy Device
Vesalio, Inc.
PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbabl
M/s. Meril Endo Surgery Private Limited.
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
Cercare Medical A/S
ProPel SG3 Surgical Gown
Standard Textile Co., Inc.
Vitrea CT VScore
Canon Medical Informatics, Inc.
AirFit F20 Mask System; AirFit F20 NM Mask System
Resmed Pty , Ltd.
Neurophet SCALE PET
Neurophet., Inc.
AIR Recon DL
Ge Medical Systems,Llc (Ge Healthcare)
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
Route 92 Medical, Inc.
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