CORE-SPORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AFS Medical Sterile Single-Use Access Port System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRIPORT, TRIPORT+, TRIPORT15, QUADPORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Laparoscopic Single Port Access Device

FDA classification

FDA Class 2 ·Laparoscopic Single Port Access Device

HTJ-2220

FDA registration

JIANGMEN HONETIAN TECHNOLOGY CO., LTD·1 product·🇨🇳 China

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

HTJ / GAUGE, DEPTH

FDA registration

LOHAR MEDICAL COMPANY·1 product·🇵🇰 Pakistan

MONTEFARMACO OTC SPA

Manufacturer

🇮🇹 Italy·17 Basic UDI-DIs·17 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., ICIM S.P.A., ICIM S.P.A., ICIM S.P.A., and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

Grahams Natural Alternatives Pty Ltd

Manufacturer

🇦🇺 Australia·1 Importer

KTJ Kunststofftechnik Junker GmbH

Manufacturer

🇩🇪 Germany

NUTRA ESSENTIAL OTC, S.L.

Manufacturer

🇪🇸 Spain

Ote Pharma Sol B.V.

Manufacturer

🇳🇱 Netherlands·1 Basic UDI-DI·1 Device

18-042-52 SUSANO Pad for Double Leg Section Type A

FDA registration

MIZUHO Corporation Chiba Factory·1 product·🇯🇵 Japan

Kyra

FDA registration

KYRA MEDICAL, INC.·1 product·🇺🇸 United States

KTEK

FDA registration

KYRA MEDICAL, INC.·1 product·🇺🇸 United States

Kyra

FDA registration

KYRA MEDICAL, INC.·1 product·🇺🇸 United States

KTEK

FDA registration

KYRA MEDICAL, INC.·1 product·🇺🇸 United States

Kyra

FDA registration

KYRA MEDICAL, INC.·1 product·🇺🇸 United States