TOTAL BILIRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE

FDA 510(k)

FDA Class 2 ·Ophthalmic

BLAINE SCARCARE PATCH

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

AST/SGOT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MYALLERGYTEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DONG BANG ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

C-76 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

POLYBONE GRANULE & BLOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

TOTAL PROTEIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

T-3 UPTAKE/RIASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Ovarian Adnexal Mass Assessment Score Test System

FDA classification

FDA Class 2 ·Ovarian Adnexal Mass Assessment Score Test System

TendoNova Ocelot

FDA UDI

Tendonova Corporation·00860009899865·TendoNova Disposable Unit 60mm Kit-Single

Microcen 24

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Álvarez Redondo, S.A.·1 device

Ferring Pharmaceuticals A/S

System producer

🇩🇰 Denmark

OKO SOLUTION

Importer

🇫🇷 France·11 Manufacturers

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MEMORYGEL BREAST IMPLANT