Toothbrush Ultraviolet Sterilizer

FDA registration

JIANGXI RISUN TECHNOLOGY CO., LTD·1 product·🇨🇳 China

Disposable Instant Ice Pack, Disposable Instant Hot Pack, Disposable Perineal Cold Pad

FDA registration

JIANGXI HANDASEN INDUSTRY CO., LTD·1 product·🇨🇳 China

Medical Headlight: JD2000, JD2100, JD2200, JD2300, JD2400, JD2500, JD2600, JD2700, JD2800, JD2900, JD3000, JD3000A,

FDA registration

NANCHANG MICARE MEDICAL EQUIPMENT CO.,LTD·1 product·🇨🇳 China

Denture Cleansing Tablet, Aligner Cleaner

FDA registration

NANCHANG WHITE TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

Aspen Medical Products

FDA registration

GLOBAL CASES (VIETNAM) CORPORATION LIMITED·1 product·🇻🇳 Vietnam

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACUITY SPIRAL LEAD FAMILY

Ti Base Detector

FDA registration

MegaGen Implant Co., Ltd. (Research Laboratories)·1 product·🇰🇷 South Korea

Ti Base Detector

FDA registration

Megagen Implant Co., Ltd.·1 product·🇰🇷 South Korea

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ACVTIVE-B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300

FDA 510(k)

FDA Class 2 ·Immunology