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
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
Philips Medizin Systeme Böblingen GmbH
XTRA Autotransfusion System (with XTRA Bowl sets)
Sorin Group Italia S.R.L.
Skanmobile, Skanmobile-Dr
Skanray Technologies Limited
Rayvolve PTX-PE
AZmed
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
Dongguanshi Yiyingmei Technology Co., Ltd.
METIC- Airway Balloon Catheter
M/S Meril Life Sciences Pvt. , Ltd.
INVOcell Intravaginal Culture System
Invo Bioscience
VEA Align; spineEOS
Eos Imaging
Q2 IV Administration Sets
Quest Medical, Inc.
AlignRT Plus
Vision Rt, Ltd.
Bullsai Confirm
Turing Medical Technologies, Inc.
SomniCheck
Brainmatterz, LLC
Brainomix 360 Triage ICH
Brainomix Limited
TRANBERG Thermoguide Therapy System
Clinical Laserthermia Systems, AB
NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultras
Nurodata, Inc.
Enhanced Boundary for PCCT
Ge Medical Systems, LLC
VarseoSmile TriniQ
Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
Baxter Healthcare Corporation
Medical Mesh Nebulizer (AirICU Max+)
AIRICU, Inc.
ZENEX Implant System_Short (R-System)
Izenimplant Co., Ltd.
Electric Breast Pump (HL-3058, F5112)
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
Anovo Pedestal
Momentis Surgical , Ltd.
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen
Edwards Lifesciences, LLC
SurGuard3 Safety Hypodermic Needle
Terumo Europe N.V.
QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test
Osang, LLC
Synguard Nitrile Exam Glove
Tianjin Aoshang Outdoor Equipment Co., Ltd.
Access Folate Assay
Beckman Coulter, Inc.
IPL Hair Removal Device (JM-843, JM-865, JM-638)
Shenzhen Junmei Technology Co., Ltd.
DEKA ACE Pump System
Deka Research and Development
Hammertoe Truss System (HTS)
4Web Medical, Inc.
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