510(k) clearances

RENASYS DYNAFLOW Kit (66807741)

Smith & Nephew Medical, Ltd.

• OMP
• Class II

MICSI-PET

Microstructure Imaging, Inc.

• KPS
• Class II

KOWA FM-600

Kowa Company, Ltd. Chofu Factory

• MYC
• Class II

ANTERION

Heidelberg Engineering GmbH

• OBO
• Class II

Single Use Ureteral Access Sheath

Zhejiang Chuangxiang Medical Technology Co., Ltd.

• FED
• Class II

DRIM-Nail System

41Medical AG

GSPE Spacer

The General Hospital Corporation, d/b/a Massachusetts

• JWH
• Class II

Mint ACE Pump

Beta Bionics, Inc.

• QFG
• Class II

Potenza Prime

Jeisys Medical Incorporated

• GEI
• Class II

Disposable Sterile Skull Drill (LZ)

Guizhou Zirui Technology Co., Ltd.

• HBF
• Class II

Surgical Power System

Guizhou Zirui Technology Co., Ltd.

• HBC
• Class II

Ecomed Disposable Administration Sets

Ecomed Solutions, LLC

• FPA
• Class II

Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)

Shenzhen Xinyan Medical Technology Co.,ltd.

• MWJ
• Class II

BoneVue

Curvebeam AI / Curvebeam, LLC

• KGI
• Class II

Extroducer Infusion Catheter System

SmartWise Sweden AB

• KRA
• Class II

SkinSmart Antimicrobial HydroGel

Magic Science Supply, LLC

• FRO
• Unclassified

Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)

Vitaltec Corporation

• BTO
• Class II

Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)

Wuhan Pioon Technology Co., Ltd.

• GEX
• Class II

EVOLUTION MPX™ Total Knee System

Suzhou Microport Orthorecon Co., Ltd.

• JWH
• Class II

Cerasmart Forte

GC America, Inc.

• EBF
• Class II

4K Camera Head OLYMPUS CH-S700-08-LB

Olympus Medical Systems Corp.

• FET
• Class II

Upper Arm Blood pressure monitor (BP7155D)

OMRON Healthcare, Inc.

• DXN
• Class II

Quicktome Software Suite

Omniscient Neurotechnology Pty, Ltd.

• QIH
• Class II

ACUNAV Luxera 4D ICE Catheter

Siemens Medical Solutions USA, Inc.

• OBJ
• Class II

Diode Laser Therapy System

Sanhe LEFIS Electronics Co., Ltd.

• GEX
• Class II