510(k) Device Clearances

IPS e.max One

Ivoclar Vivadent, AG

PreOp v3

Clouds of Care

SAM Model 9-10000

Snap Diagnostics, LLC

Hudson RCI Comfort Flo® CubCannula™

Medline Industries, LP

Disposable Distal Cap

Mirco-Tech (Nanjing) Co., Ltd.

SKR 3000

Konica Minolta, Inc.

Gemini 2 810+980 Soft Tissue Laser

Azena Medical, LLC

BLU TOTALE (Model: ENEOB852)

Premier North America, Inc.

Venue Fit

GE Medical Systems Ultrasound and Primary Care Diagnostics

VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); V

Wellell, Inc.

MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)

Beckman Coulter, Inc.

EchoMeasure

Icardio.Ai

HomeSleepTest (HST, HST REM+)

Somnomedics GmbH

Biomet Kirschner Wires (K-Wires)

Biomet, Inc.

Materialise TKA Guide System

Materialise NV

MeVis Liver Suite

MeVis Medical Solutions AG

Dong Hai Xiang Surgical Mask

Taizhou Donghaixiang Protective Equipment Co., Ltd.

BruxZir® Radiant

Prismatik Dentalcraft, Inc.

Excipio LV Prime Thrombectomy Device

Contego Medical, Inc.

RODIN 3D Resin SPLINT, Hard/Flex

Belport Company, Inc., Gingi-Pak

DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

Sorin Group Italia S.R.L.

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

Gm Dos Reis Industria E Comerico Ltda.

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)

Medtronic, Inc.

TDM Large Bone Plate and Screw System

Tdm Co., Ltd.

Dasky Disposable Sampling Tube (Model name: VSM02)

Ningbo Dasky Life Science Co., Ltd.

BeautiBond Xtreme

Shofu Dental Corporation

Single-Use Flexible Ureteroscope

Hunan Vathin Medical Instrument Co., Ltd.

Saige-Dx

DeepHealth, Inc.

Portable X-ray System

Iray Technology Taicang , Ltd.

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

M.I.Tech Co., Ltd.