510(k) Device Clearances

Kontact Dental Implant System

Biotech Dental, Sas

AI-CVD

HeartLung Corporation

Evidence MultiSTAT DOA Urine MultiPlex

Randox Laboratories Limited

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws

Avanti Orthopaedics, Inc.

Velox Power Chair

Velox Manufacturing, Inc.

Purism Non-Sterile Powder Free Nitrile Examination Gloves

Dezhou Purism Medical Technology Co., Ltd.

Phasix ST Umbilical Hernia Patch

Davol, Inc., A Subsidiary of C.R. Bard, Inc.

Halo One Thin-Walled Guiding Sheath

C.R. Bard, Inc.

Caption Interpretation Automated Ejection Fraction Software

Caption Health

6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

Esaote, S.p.A.

Pen Injector Needle 32.5

Terumo Corporation

Vydence Family of Lasers

Vydence Medical Industria E Commercio Ltda

Lunit INSIGHT DBT (V1.2)

Lunit, Inc.

8 mm Assist Cannula; 12 mm Assist Cannula

Intuitive Surgical, Inc.

Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citr

Ksg Medicare Sdn. Bhd.

Nulife

Mrk Healthcare Pvt, Ltd.

Sofjec

Hwajin Medical Co., Ltd.

Limfa Therapy System (Limfa Therapy)

Eywa Srl

MixJect® Transfer Device

West Pharma. Services IL, Ltd.

5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)

Shenzhen Beacon Display Technology Co., Ltd.

Alegria Flash CTD Screen

Zeus Scientific

CustomSurg OrthoPlanner

Customsurg AG

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

Gm Dos Reis Industria E Comerico Ltda.

SOMATOM Pro.Pulse

Siemens Medical Solutions USA, Inc.

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

Nyu Langone Medical Center

Control-IQ+ technology

Tandem Diabetes Care, Inc.

RW-1

Mediott, Inc.

Rapid CTA 360

Ischemaview

Surgical Mask

Wuhan Zonsen Medical Products Co., Ltd.

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s

Edan Instruments, Inc.