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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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