510(k) Device Clearances

ILR ECG Analyzer (IM007)

Implicity, Inc.

DenMat Bulk Fill Composite

Den-Mat Holdings, LLC

GF85 (models GF85-3P, GF85-SP)

Samsung Electronics Co., Ltd.

Tornier Pyrocarbon Humeral Head

Tornier S.A.S.

Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)

Hubei Yjt Technology Co.,Ltd

Portable Oxygen Concentrator (Model: P2-E7, P2-E)

Qingdao Kingon Medical Science and Technology Co., Ltd.

eCARTv5 Clinical Deterioration Suite (“eCART”)

Agilemd, Inc.

Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fenta

O&M Halyard, Inc.

Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1

Turbett Surgical

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staple

Wuxi Beien Surgery Device Co., Ltd.

PRIMED Surgical Masks and PRIMED Procedure Masks

Primed Medical Products, Inc.

Acu-Sinch Knotless Mini

Acumed, LLC

Digital Radiography CXDI-Pro, Digital Radiography D1

Canon, Inc.

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powde

Hartalega NGC Sdn. Bhd.

Paltop Conical Implant System

Paltop Advanced Dental Solutions, Ltd.

EdgeFlow Gel Pad

Edgecare, Inc.

Metal Cannulated Screw

Double Medical Technology, Inc.

BTL-754FF

BTL Industries, Inc.

DePuy Synthes Retrograde Femoral Nail Advanced System

DePuy Synthes

MRCAT Head & Neck

Philips OY

PolyWear® Personal Protective Level 3 Gown

PolyConversions, Inc.

F3

Acrew Imaging, Inc.

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)

Coloplast

NemoCast

Software Nemotec S.L.

Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)

Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd.

HemosIL ReadiPlasTin

Instrumentation Laboratory CO

CoolSeal Trinity

Bolder Surgical, LLC

N1 TiUltra TCC Implant System

Nobel Biocare Services AG

Quantum Perfusion Hybrid System

Spectrum Medical S.R.L.

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml

Thermo Fisher Scientific