510(k) Device Clearances

PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7

Smith and Nephew Medical Limited

ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))

1987 Media Limited

Osprey Suture Anchor

Responsive Arthroscopy, Inc.

GR Splint Resin System

Pro3Dure Medical GmbH

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

Assure Tech. (Hangzhou) Co, Ltd.

NUNA LUX (NUNL528)

Premier North America, Inc.

TK Pre-Filled Normal Saline Flush Syringe

Anhui Tiankang Medical Technology Co., Ltd.

Ceribell Infant Seizure Detection Software

Ceribell, Inc.

iOrtho

Shanghai EA Medical Instruments Co., Ltd.

Elvie Stride

Chiaro Technology Limited

EliA Rib-P

Phadia AB

CellFX System

Pulse Biosciences, Inc.

TransForm McCarthy Mitral Annuloplasty Ring (TF)

Genesee Biomedical, Inc.

NIO-I

Einstein Works, LLC

Elite Biomedical Solutions Dose Request Cord

Elite Biomedical Solutions

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultra

Samsung Medison Co., Ltd.

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

Philips Medizin Systeme Boeblingen GmbH

Synapse PACS (7.6.0)

FUJIFILM Healthcare Americas Corporation

ECHO Photocoagulator

Norlase

X-CUBE 70

Alpinion Medical Systems Co., Ltd.

Altor Safety 3-Ply Surgical Mask (Model:62222)

Altor Safety, LLC

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgica

Dongguan Shin YI Healthcare Products Factory

CastleLoc-S Posterior Cervical Fixation System

L&K BIOMED Co., Ltd.

Remi Robotic Navigation System

Fusion Robotics, LLC

GEM Premier 7000 with IQM3

Instrumentation Laboratory Company

SeptAlign

Spirair, Inc.

Disposable Medical Mask

Dong Guan Kinyet Metal Products Co., Ltd.

Spectrum IQ Infusion System with Dose IQ Safety Software

Baxter Healthcare Corporation

MapRT

Vision Rt, Ltd.

BioFire Joint Infection (JI) Panel

Biofire Diagnostics, LLC