510(k) clearances

OTOPLAN

Cascination AG

• QQE
• Class II

RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)

Smith & Nephew Medical, Ltd.

• OMP
• Class II

DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent

Medtronic

BlineSlide

Deep Breathe, Inc.

• POK
• Class II

Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Single Spike, Tubing 80, with Luer Lock - Sterile (30034); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 80, with Luer Lock- Sterile (30035); Polymed TUR Irrigation Set, Y- Type, 4 Leads

Poly Medicure Limited

• LJH
• Class II

EASYMAX Voice Blood Glucose Monitoring System

EPS Bio Technology Corp.

• NBW
• Class II

VENTANA MMR IHC Panel

Roche Tissue Diagnostics, Inc.

• PZJ
• Class II

Kinetic Software Library

Monebo Technologies, Inc.

• DPS
• Class II

LuxDesign

LuxCreo, Inc.

• PNN
• Class II

B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC

B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)

• SJQ

Mobile Dental Solution (Model: DS50, DS70, DS90)

Guangdong JINME Medical Technology Co., Ltd.

• EIA
• Class I

BreathCare PAP III (YH-390N)

Suzhou Yuyue Medical Technology Co., Ltd.

• BZD
• Class II

OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens

Visco Vision, Inc.

• LPL
• Class II

Veritas Shoulder System

restor3d, inc.

• PHX
• Class II

Xpert Xpress CoV-2/Flu plus

Cepheid®

• QOF
• Class II

PicoPeak Picosecond Nd:Yag Laser System (Bella-9)

Beijing Sea Heart International Science and Technologyco.Ltd

• GEX
• Class II

GANNET®

BAAT Medical Products B.V.

• JDO
• Class II

Cerclage Wires;K-wires;Steinmann Pins

MK Medical GmbH

• HTY
• Class II

S.I.N. Instruments Kits

S.I.N. Implant System Ltda

• KCT
• Class II

FAQ™ (FAQ 411)

Foreo, Inc.

• NFO
• Class II

MultiNeO Dental Implant System

Alpha Bio Tec , Ltd.

• DZE
• Class II

Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-125X25AA); Accelagen Advanced Surgical Collagen Strip, 250x25x2mm (CG-250X25AA)

Berkeley Advanced Biomaterials

• KGN
• Unclassified

Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter

Zylox Medtech Co., Ltd.

• PNO
• Class II

Gravity Blood Sets with 200µm Filter

B.Braun Medical, Inc.

• FPA
• Class II

Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)

Suzhou Medical Appliance Factory

• BWK
• Unclassified