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
3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest A
3M Company
Withings BeamO (SCT02)
Withings
Faros Surgical System
Oertli Instrumente AG
Arthrex Humeral Nails
Arthrex, Inc.
Phagenyx System
Phagenesis Limited
Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
Ningbo Ranor Medical Technology Co., Ltd.
Vital Spinal Fixation System
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Philips IntelliSite Pathology Solution
Philips Medical Systems Nederland B.V.
Normatec Elite Hip
NormaTec Industries, LP
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
Bytech(Dongtai) Co., Ltd.
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
Nb Medical Company Limited
BEAR® (Bridge-Enhanced ACL Restoration) Implant
Miach Orthopaedics, Inc.
Niti-S Biliary Speed D Stent
Taewoong Medical Co., Ltd.
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
Olympus Medical Systems Corp.
VerteLoc Spinal System
Signature Orthopaedics Pty, Ltd.
DD Hybridlayer (multicolored zirconia)
Dental Direkt GmbH
Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color
Guangdong Kingfa Sci. & Tech.Co., Ltd.
HYALOMATRIX
Anika Therapeutics, Inc.
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
Wuxi Jiajian Medical Instrument Co., Ltd.
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
Nihon Kohden Corporation
EnDrive (EnDriveUS)
Advanced Technology Research (A.T.R.) S.R.L.
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
Arc Trauma, LLC
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open N
Neocoil, LLC
Vent Creativity Knee v1.0 (Hermes)
Vent Creativity
ExcelsiusGPS Instruments
Globus Medical, Inc.
CardIQ Suite
GE Medical Systems SCS
Alinity i STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Division
MSFX Mikron Cervical Anterior Plate System
Mikron Makina Sanayi VE Ticaret Ltd. Sti.
PlanOne 1
Cosylab Jsc, Control System Laboratory
eFOLDi Scooter, Lite
Suntech UK , Ltd.
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