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
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL
Thermo Fisher Scientific
Aspirex Thrombectomy System
C.R. Bard, Inc.
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
Thrombolex, Inc.
GelPOINT V-Path Vaginal Access System
Applied Medical Resources Corporation
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
Steelco S.P.A.
Eyer Retinal Camera NM-STD
Phelcom Technologies
SubtleHD-CT (1.x)
Subtle Medical, Inc.
Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plu
Sonoscape Medical Corp.
GLAM LED Facial Mask (TB-2386F)
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
PrimeSight UltraView System
Cogentix Medical, Inc.
GlasIonomer FX-LC
Shofu Dental Corporation
iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
Sleepnet Corporation
Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Steri
Jiangsu Kangbao Medical Equipment Co., Ltd.
BPS - Bone Fragment Fixation Plates, Screws and Washers
Orthonovis, Inc.
OptiVu ROSA MxR
Orthosoft Inc (D/B/A Zimmer Cas)
MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
Menicon Co, Ltd.
Syneris PACS v.1.0.1.0
Syneris
Access SHBG
Beckman Coulter, Inc.
ELEC ENGINE (Model: ISE-170L)
Micro-Nx Co., Ltd.
Cold Compression
Jkh Health Co., Ltd.
Aura Glide (FC40)
Aura Medical, LLC
JETi Hydrodynamic Thrombectomy System
ABBOTT MEDICAL
BioFire COVID-19 Test 2
Biofire Defense, LLC
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Merit Medical Ireland, Ltd.
Syntex Exam Gloves
Basic Medical Technology, Inc.
Luminopia
Luminopia, Inc.
Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
Zibo Sinocare Plastic Products Co., Ltd.
Power Wheelchair (W5915B, W5915C, W5915D)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
MagDI System (MAG-01, DS-01)
Gt Metabolic Solutions, Inc.
BD MAX Enteric Parasite Panel
Becton, Dickinson and Company
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