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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

MAC 7 Resting ECG Analysis System

Ge Medical Systems Information Technologies, Inc.

LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)

Huizhou Foryou Medical Devices Co., Ltd.

Lumify Diagnostic Ultrasound System

Philips Ultrasound

Luvis Chair (LC700C)

Dentis Co., Ltd.

Intense Pulsed Light Therapy Device

Sanhe LEFIS Electronics Co., Ltd.

CastleLoc Pectus Bar System

L&K BIOMED Co., Ltd.

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)

Guangzhou Sonostar Technologies Co., Ltd.

Venous Return Cannulae

LivaNova USA, Inc.

JADE SCORE PTA Scoring Balloon Dilatation Catheter

OrbusNeich Medical (Shenzhen) Co., Ltd.

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™

Bone Solutions, Inc.

Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope

Shanghai Caremate Medical Device Co., Ltd.

Jazz

Ai Medical AG

Yumizen H550

HORIBA ABX SAS

Anika Tissue Tack Fixation System

Anika Therapeutics, Inc.

LithoVue Elite Digital Flexible Ureteroscope System

Boston Scientific Corporation

Aperio GT 450 DX

Leica Biosystems Imaging, Inc.

Latex Examination Glove Powder Free (Ocean Blue and Natural White)

Sri Trang Gloves (Thailand) Public Company Limited

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

Wilson-Cook Medical, Inc.

CYLOX® ST

Signus Medizintechnik GmbH

OC JuggerKnot Soft Anchor

Riverpoint Medical

Delivery Date AI

Ultrasound AI

Surgical Masks

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

AVIEW Lung Nodule CAD

Coreline Soft Co., Ltd.

Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit

Maduro Medical, Inc.

Sysmex XW-100 Automated Hematology Analyzer

Sysmex America, Inc.

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™

3M Company

LORRAINE 2.5/3.5mm Distal Humerus System

Bonebridge AG

Grandio disc multicolor

Voco GmbH

PM2+ System and SmartPICC Stylet

Piccolo Medical, Inc.

Plasonic (Plasonic)

Hironic Co., Ltd.

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