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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

HemoCare Hemodialysis System

Deka Research and Development

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)

Staclear, Inc.

Ziehm Solo FD

Ziehm Imaging GmbH

Hyper Insight - ICH

Sk, Inc.

Respiratory Gating for Scanners (2.1)

Varian Medical Systems, Inc.

Cystoscope System

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

Edma Group, LLC

PICOANDY (Q-Switched Nd:YAG Laser)

Wontech Co., Ltd.

Fractional CO2 Laser Machine

Zhengzhou PZ Laser Slim Technology Co., Ltd.

Servator P SALF Solution with THAM

S.A.L.F. Spa

c-med0 alpha

Cosinuss GmbH

Cardio P1

Bionet Co., Ltd.

Dental Implant Unit

Guilin Aesthedent Medical Instruments Co., Ltd.

UNITY Sacroiliac Joint Fixation System

Dio Medical Corporation

uWS-Angio Basic

Shanghai United Imaging Healthcare Co., Ltd.

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)

Osteonic Co., Ltd.

YSI 2900C Biochemistry Analyzer

Ysi, Inc.

JETT PLASMA Medical II

Compex, Spol, S.R.O.

SOUNDSTAR™ CRYSTAL Ultrasound Catheter

Biosense Webster, Inc.

PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves

O&M Halyard, Inc.

Task Force CORE

Cnsystems Medizintechnik GmbH

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

Artsmedia Denmark Aps

PacePro Wire

Opsens, Inc.

VASSALLO GT 018 Floppy

Filmecc Co., Ltd.

SmartGUIDE deflectable hydrophilic guidewire

Artiria Medical SA

AI-Rad Companion Organs RT

Siemens Healthcare GmbH

Neuromuscular Transmission Monitor TOF3D

MIPM Mammendorfer Institut für Physik und Medizin GmbH

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay

Immunalysis Corporation

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

MacroLux Medical Technology Co., Ltd.

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

Xiros, Ltd.

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