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
Conical Platform Dental Implants System
Noris Medical , Ltd.
IntraLock System
Fusion Orthopedics, LLC
ORiGO System
Bien-Air Surgery SA
STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOC
Advanced Sterilization Products, Inc.
Primary Relief
Dyansys, Inc.
sam CS Long Duration Ultrasound Device
ZetrOZ Systems, LLC
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
Gt Metabolic Solutions, Inc.
Disposable Monopolar Laparoscopic Tips and Reusable Handles
Dannik, LLC
Hexa-Temp
Spident Co., Ltd.
SuperBall Meniscal Repair System
Arcuro Medical , Ltd.
Intra.Ox 2.0 Handheld Tissue Oximeter
Vioptix, Inc.
BriefCase-Quantification
Aidoc Medical , Ltd.
Tegamen Nitrile Examination Gloves
M/S Tegamen Safety Products Private Limited
Embosphere Microspheres
Biosphere Medical, S.A.
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
Vinno Technology (Suzhou) Co.,Ltd
Terran NM-101
Terran Biosciences, Inc.
ROSA Knee System with UltraSound Imaging Platform (USIP)
Balmoral Medical, LLC
Ultrasonic Surgical System
Miconvey Technologies Co., Ltd.
APERTO Lucent MRI System
FUJIFILM Healthcare Americas Corporation
T-Edge 10, T-Edge 11
Tuttnauer , Ltd.
Annex® 2 Adjacent Level System
Spine Wave, Inc.
VirtuOst
O.N. Diagnostics
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
Prosidyan, Inc.
SilentZPro 2.0
Shinrin-Yoku Traders, LLC
SpineSite Endoscope System
Hydrocision, Inc.
PeekMed web
Peek Health, S.A.
Medline UNITE® Medial Malleolus Peg Plate System
Medline Industries, LP
Disposable Surgical Face Mask
Shandong Zhushi Pharmaceutical Group Co., Ltd.
TECHFIT DISRP® System
Techfit Digital Surgery, Inc.
Surgical Face Mask
Hubei Yi-Ya Protective Products Co., Ltd.
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