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
Disposable Medical Surgical Mask
Jiangxi Bestgrand Health Technology Co., Ltd.
J-Temp
Ultradent Products, Inc.
MDx-Chex for BC-GN
Streck
IPL Hair Removal
Shenzhen Qiaochengli Technology Co., Ltd.
SACS PRO
Elastimed , Ltd.
HydraDose Vaginal Suppositories
MD Labs, LLC
Electric Scooter (M2085, S2091)
Guangdong Prestige Technology Co., Ltd.
I.V. Administration Set
Bq Plus Medical Co., Ltd.
SafePort(TM) Manifold (or Stopcock)
Elcam Medical Acal
angiOCCLUDE Ligating Clips
A2 Medical Systems, LLC
Warantec Custom Abutment
Warantec Co., Ltd.
FAMA Male Latex Condoms
Shanghai Personage Hygiene Products Co., Ltd.
Fogg System Patient Monitoring Cables
Fogg System Company, Inc.
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
Fresenius Medical Care Renal Therapies Group, LLC
Vecttor VT-300
Artaflex, Inc.
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
myAir
Resmed Corp
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and F
Central Medicare Sdn Bhd
OviTex PRS
TELA Bio, Inc.
Ventripoint Medical System Plus (VMS+) 4.0
Ventripoint Diagnostics , Ltd.
Synchfix EVT
Wright Medical Technology, Inc. (Stryker Corporation)
Mjolnir Pro. (Multielectrode plasma)
Shenzhen Leaflife Technology Co., Ltd.
Zeta Cranial Navigation System
Zeta Surgical
EKGenius Smart System
Ekgenius, LLC
ADSEAL Plus
Meta Biomed Co., Ltd.
Diode laser device (BM091)
Hebei Newangie Technology Co., Ltd.
United Orthopedic Knee Patient Specific Instrumentation
Enhatch, Inc.
Annalise Enterprise CTB Triage-OH
Annalise-Ai Pty , Ltd.
Persona® Personalized Knee System
Zimmer Switzerland Manufacturing GmbH
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1);
Surgify Medical OY
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