510(k) Device Clearances

Green OR Reprocessed Aquamantys Bipolar Sealer

Green Or, LLC

Portare System (FA-001)

Grumpy Innovation, Inc.

DigiLine Direct Print Aligner System

Park Dental Research Corporation

Revogene

Meridian Bioscience, Inc.

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono

Genoss Co., Ltd.

Nuvis® Wireless HD Camera System (Nuvis-2K)

Integrated Endoscopy, Inc.

WatchPAT200U (WP200U)

Itamar Medical , Ltd.

INNOVISION-EXII

Dk Medical System

Sure-Fine Insulin Syringes

Shina Med Corporation

VR® Personal Protective Level 4 Gown (VR Gowns)

PolyConversions, Inc.

KHEIRON® Spinal Fixation System, including patient specific K-ROD

S.M.A.I.O

Onera STS 2 (ONERA STS 2)

Onera B.V.

Medical nitrile examination gloves (Model: SH001)

Jiangxi Sanhao Medical Instruments Co.,Ltd

Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Sing

Owen Mumford, Ltd.

IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA

Siemens Healthcare Diagnostics Products, Ltd.

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Koh Young Technology, Inc.

Leksell GammaPlan (LGP)

Elekta Solutions AB

PINE Pedicle Screw System

Tdm Co., Ltd.

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

VPIX Medical, Inc.

Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system

Medtronic

Alians Elbow S

Newclip Technics

Monarch Blood Collection Set

The Monarch Company

Green Card Bowie-Dick Test (BD115)

Steritec Products, Inc. (A Getinge Company)

Mazor X System (Mazor X Stealth Edition)

Mazor Robotics , Ltd.

Enamel Coating Resin

Rizhao Huge Biomaterials Company, Ltd.

ClotTriever XL Catheter

Inari Medical, Inc.

TubaVent Balloon Dilatation System

Spiggle & Theis Medizintechnik GmbH

VINT

Mediimg Corporation

RhinAer® Stylus (FG1393)

Aerin Medical, Inc.

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

Quidel Corporation