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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

Eonis SCID-SMA Kit

Perkinelmer, Inc.

3D-RD-S

Radiopharmaceutical Imaging and Dosimetry, LLC

AIROS 6P Sequential Compression Device

Airos Medical, Inc.

Vision Monitor- MonCvONE

Metrovision

LINQ II™ Insertable Cardiac Monitor (LNQ22)

Medtronic, Inc.

SENSOSEEG Depth Electrodes

Sensomedical Labs, Ltd.

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/

Thermo Fisher Scientific

Technozym ADAMTS13 Activity

Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM

Profoject™ Disposable Needle

CMT Health PTE., Ltd.

PRO Plating System, Stryker Trauma Pelvic Set (Matta)

Stryker GmbH

DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder);

Kamemizu Chemical Industry Co., Ltd.

TEMP MASTER, PMMA-based dental resin

Taiwan Dental Materials Co., Ltd.

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR1

Hunan Endoso Life Technology Co., Ltd.

EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekt

Elekta Solutions AB

KLS Martin Pure Pectus System

KLS-Martin L.P.

SimPro™ Now, GentleCath™ Hydrophilic

Dentsply Sirona

Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q G

Stryker Leibinger GmbH & Co KG

QIAstat-Dx GI Panel 2 Mini B

QIAGEN GmbH

Ultrasound Transducer Cover

Vitrolife Sweden AB

VizMark Preloaded Tissue Marker Device (VM-0001)

Breast-Med, Inc.

Quantra QStat Cartridge

Hemosonics, LLC

Microdent Sterilization Cassette

Implant Microdent System S.L.U.

Total Flow Medical Femoral Arterial (TFA) cannula

Total Flow Medical Limited

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)

Nxstage Medical, Inc.

Cleaner Plus Thrombectomy System

Argon Medical Devices, Inc.

Spinal System

Teslake, Inc.

Axis Anterior Cervical Plate System

Southern Medical (Pty) , Ltd.

OptiVu™ ROSA® MxR

Orthosoft Inc (D/B/A Zimmer Cas)

PureLift Pro Max

Xtreem Pulse, LLC

Digital ClarusScope System; Digital NeuroPEN System

Clarus Medical, LLC

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