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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

HistoSonics® Planning Tool

HistoSonics, Inc.

Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Hood (DH-083ST)

Fujifilm Corporation

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20

Asahi Intecc Co., Ltd.

PRIMED Pediatric Facemask

Primed Medical Products, Inc.

ARROW Off-Centred Humeral Insert

FH Industrie

VenAir, Sequential Compression System

Apex Medical Corp.

SMR Shoulder System

Lima Corporate S.P.A.

NEXUS® Hip Stem

Microport Orthopedics, Inc.

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS

Tuttnauer , Ltd.

Disposable Medical Surgical Mask

Hubei Huaqiang High-Tech Co., Ltd.

CastleLoc-P Anterior Cervical Plate System

L&K BIOMED Co., Ltd.

CiRX Single use electrosurgical pencil with non-coated and coated electrode

Ningbo Shun YE Medical Company, Ltd.

Verisafe Safety Retractable Insulin Syringes

Promisemed Hangzhou Meditech Co., Ltd.

Zavation Spinal System

Zavation Medical Products, LLC

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

REDEMPTION Beaming System

Vilex, LLC

Durex Patronus Wide

Rb Health (Us), LLC

Elecsys proBNP II, Elecsys proBNP II STAT

Roche Diagnostics

Penumbra LP Coil System

Penumbra, Inc.

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser

Ids, Limited

Arrow 0.2 Micron Flat Filter, GVS

Arrow International, LLC

ARTAssistant

Manteia Technologies Co., Ltd.

Open Rib

Canon Medical Informatics, Inc.

CROSSLEAD Penetration Peripheral Guide Wire

Asahi Intecc Co., Ltd.

Spirair Nasal Septal Strap

Spirair, Inc.

Neteera 130H-Plus Vital Sign Monitoring Sensor

Neteera Technologies , Ltd.

Clungene RSV Antigen Rapid Test

Hangzhou Clongene Biotech Co., Ltd.

Single-use Sterile High-pressure Angiographic Syringes and Accessories

Shenzhen Boon Medical Supply Co., Ltd.

Fogg System Patient Monitoring Cables

Fogg System Company, Inc.

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