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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

Miro3D Wound Matrix

Reprise Biomedical, Inc.

Wrist Blood Pressure Monitor

Zhuhai Yueja Medical Device Technology Co., Ltd.

Microstream CO2 NanoPod

Covidien, LLC

UltraScore™ Focused Force PTA Balloon

Bard Peripheral Vascular, Inc.

Diode Laser Therapy Device (DF-DIODE LASER-S1)

Weifang Dragonfly Electronics Technology Co., Ltd.

Velano Vascular Blood Collection Adapter

Velano Vascular

New Day Skin Spray

Silk Holdings, Inc.

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

Methyl Co., Ltd.

IPDmilled Blanks

Implant Protesis Dental 2004, S.L.

ProSeal™ In Line Pump Set (423850)

Epic Medical Pte. , Ltd.

Crossloop

Asahi Intecc Co., Ltd.

Single-Use Biopsy Valve (MAJ-1555)

Olympus Medical Systems Corporation

ONO Retrieval Device

Onocor Vascular, LLC

ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36

Tools For Surgery, LLC

ClearPoint System (Software Version 3.0)

ClearPoint Neuro, Inc.

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4

Biosense Webster, Inc.

MIM – LesionID Pro

Mim Software, Inc.

MDx-Chex for BC-GP

Streck

EzVu Visual Vasopressor injector (EV-19)

Veol Medical Technologies Pvt , Ltd.

Gas Insufflator

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

10THERMA

Tentech, Inc.

Ruthinium Disc

Dental Manufacturing S.p.A.

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator

STERIS Corporation

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

Tigon Medical

HELIOS 785 Pico (1754V2)

Laseroptek Co., Ltd.

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

Biofire Diagnostics, LLC

SkyWalker Total Knee System

Microport Navibot International, LLC

CeraRoot TL Implant System (TL)

Ceraroot SL

OdneClean

Odne AG

SnapshotNIR model KD205

Kent Imaging, Inc.

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