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
LOGIQ E10s, LOGIQ Fortis
GE Healthcare
OmniTom Elite
Neurologica Corporation
CINtec Histology
Ventana Medical Systems, Inc.
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201
Zhejiang Lude Technology Development Co., Ltd.
Bolt Intravascular Lithotripsy (IVL) System
Bolt Medical, Inc.
Portable Dental X-ray Device (GT-1)
Guilin Refine Medical Instrument Co., Ltd.
Insulin Syringe
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
BioClean Implant Restorative System
Bioclean Dental, LLC
Helios+ UV-C System
Preventamed Technologies, Inc. Dba Surfacide Manufacturing
Latex Examination Powder Free Gloves
Aspen Glove Sdn. Bhd.
StrokeSENS ASPECTS Software Application
Circle Cardiovascular Imaging, Inc.
Syncron-E
Autonomous Healthcare, Inc.
Atalante X
Wandercraft SAS
AI4CMR v1.0
Ai4medimaging Medical Solutions S.A.
Dental Implants and Abutments
Ditron Dental, Ltd.
DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System
Synthes GmbH
BresoDX1
Bresotec, Inc.
Luna Dental Implant System
Shinhung Mst Co., Ltd.
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Trans
Stryker Sustainability Solutions
Fusion Bioline Vascular Graft
Maquet Cardiovascular, LLC
Arthrex Variable Angle (VA) Proximal Tibia Plating System
Arthrex, Inc.
Syngo Carbon Clinicals (VA41)
Siemens Healthineers AG
Invictus Robotic Navigation Instruments
Alphatec Spine
TrainFES Advance
Trainfes
Hemafuse System
Sisu Global Health
Fitbit Irregular Rhythm Notifications
Fitbit, Inc.
MFG-05
Zimmer Medizinsysteme GmbH
OSSIX Breeze
Datum Dental, Ltd.
EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
Olympus Medical Systems Corporation
ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
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