510(k) Device Clearances

Fetal Pillow

CooperSurgical, Inc.

ODI-Tech

Odi Medical AS

Promisemed Insulin Pen Needle

Promisemed Hangzhou Meditech Co., Ltd.

Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

Shenzhen Roundwhale Technology Co. , Ltd.

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

E.O.S Co., Ltd.

GlasIonomer FX-LC

Shofu Dental Corporation

Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14

Poly Medicure Limited

STERRAD 100NX Sterilization System with ALLClear Technology (10104)

Advanced Sterilization Products, Inc.

Arthrex SutureTape

Arthrex, Inc.

Power Acute Triple Lumen Hemodialysis Catheter

Health Line International Corporation

Airdog X8 Air Purifier (KJ800F-X8)

Suzhou Beiang Smart Technology Co., Ltd.

Disposable Endoscopic Distal Attachments

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)

The Beauty Tech Group, Ltd.

Lantern® Hip

Orthalign, Inc.

TECHFIT Diagnostic Models

Techfit Digital Surgery, Inc.

Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introd

William Cook Europe Aps

F&P Airvo 3

Fisher & Paykel Healthcare

lntravascular Administration Sets with Stopcock and Manifold

Baxter Healthcare Corporation

35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS S

Winner Medical Co., Ltd.

MiPACS V5 (1.0.0)

Apryse Software Corp

Drakon™ and Sequre® Microcatheters

Accurate Medical Therapeutics

CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor

Verathon Medical (Canada) Ulc

PureLift Pro Plus

Xtreem Pulse, LLC

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3

Homtex, Inc.

MAXXOS P.A.C.E. Foot & Ankle Plating System

Maxxos Medical GmbH

Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, N

Nihon Kohden Corporation

Secret MAX Multi-platform RF System

Ilooda Co,., Ltd.

Intelligent NR

Canon, Inc.

BTL-094

BTL Industries, Inc.

spineEOS

Eos Imaging