510(k) Device Clearances

Disposable Pen Injector (KXYC-03C02, KXYC-03A03)

Jiangsu Enjosim Medical Technology Co., Ltd.

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield

Unicoglobal, Inc.

MICROLET®NEXT 2 Lancing Device

Ascensia Diabetes Care U.S., Inc.

Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).

Barco N.V.

CHIKAI Nexus petit

Asahi Intecc Co., Ltd.

Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-

Selio Medical Limited

Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs

Institut Straumann AG

MPO Hip Instruments

Microport Orthopedics, Inc.

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Ulrich GmbH & Co. KG

Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)

Zibo Kaiyue Mould Technology Co., Ltd.

Vascette HP (hemostatic pad)

Koag, LLC

Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)

Cnc Technologies

Phantom Metatarsal Shortening System

Paragon 28, Inc.

Target Xtra Detachable Coil

Stryker Neurovscular

Airgle Room Air Purifier

Airgle Corporation

CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0

MacroLux Medical Technology Co., Ltd.

IPL Hair Removal Device Models: MLY-T069

Miley Technology (Hebei) Co., Ltd.

Remanufactured EndoWrist Tenaculum Forceps (420207)

Rebotix

Access 25(OH) Vitamin D Total

Beckman Coulter, Inc.

MA-40, MA-112

Medify Air, LLC

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diff

Ganshorn Medizin Electronic GmbH

Hisense LCD monitor HMD2G21S, HMD3G21S

Qingdao Hisense Medical Equipment Co., Ltd.

Durashield Device Kit

SurGenTec, LLC

Dukal Crepe Paper Sterilization Wrap

Dukal, LLC

Digital Temp

Sprintray, Inc.

LIJIA Night Guard

Lijia, LLC

BOND MMR Antibody Panel

Leica Biosystems Newcastle, Ltd.

Wearable Breast Pump (Model W12)

Shenzhen TPH Technology Co., Ltd.

Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors

Responsive Arthroscopy, LLC

Electric Breast Pump, model: YM-8166

Guangdong Youmeng Electrical Technology Co., Ltd.