Kosmos OTS Application

FDA registration

ECHONOUS, INC.·5 products·🇺🇸 United States

Kosmos

FDA 510(k)

FDA Class 2 ·Radiology

WoundExpress Pump, WoundExpress Garment

FDA registration

ARJOHUNTLEIGH LOGISTICS·1 product·🇳🇱 Netherlands

WoundExpress Pump

FDA registration

HUNTLEIGH HEALTHCARE LTD.·1 product·🇬🇧 United Kingdom

WoundExpress Pump

FDA registration

Arjo (Suzhou) Co., Ltd.·1 product·🇨🇳 China

Medley Hybrid Lubricant

FDA registration

GOOD CLEAN LOVE, INC.·1 product·🇺🇸 United States

DeRoyal

FDA UDI

DEROYAL INDUSTRIES, INC.·00749756141284·Resistive Exercise Cord

Relivion

FDA registration

NEUROLIEF Inc.·1 product·🇺🇸 United States

Safecheck Gusseted Sterilization Reel(KR12100)

Device

EU MDR · Eu Md Class 1 ·Medster Tıbbi Cihaz ve Sağlık Hizmetleri Ltd. Şti.·On the market

N.A.

FDA UDI

Forestadent Bernhard Förster GmbH·EFOR75212121001·Buccal tube Andrews .018" f. weld. max. 6 left

JOBST Elvarex

FDA UDI

BSN-Jobst GmbH·04019702399745·E2/AG/CT-E/NOP5-T-OH/BR

HONOUR™ Spacer System

FDA UDI

NEXXT SPINE, LLC·00889929002896·Cervical PEEK, 6°, 12mm W x 12mm D x 10mm H

Ti-Fix OLIF Spacer

FDA UDI

Tyber Medical LLC·M695P32121000·Ti-Fix OLIF Spacer 32 x 12 x 10 (mm) x 0 °

iBed Wireless

FDA UDI

STRYKER CORPORATION·07613327519938·

Safecheck Gusseted Sterilization Reel(KR12100-70)

Device

EU MDR · Eu Md Class 1 ·Medster Tıbbi Cihaz ve Sağlık Hizmetleri Ltd. Şti.·On the market

Safecheck Gusseted Sterilization Reel(KR12100-3)

Device

EU MDR · Eu Md Class 1 ·Medster Tıbbi Cihaz ve Sağlık Hizmetleri Ltd. Şti.·On the market

M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

POWDERED VINYL EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

Safecheck Gusseted Sterilization Reel(KR12100-70-3)

Device

EU MDR · Eu Md Class 1 ·Medster Tıbbi Cihaz ve Sağlık Hizmetleri Ltd. Şti.·On the market

HONOUR™ Spacer System

FDA UDI

NEXXT SPINE, LLC·00889929002902·Cervical PEEK, 0°, 12mm W x 12mm D x 10.0mm H