Serana Europe GmbH

Manufacturer

🇩🇪 Germany

Hospedia Medicare Pvt Ltd

Manufacturer

🇮🇳 India

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Aspire Cristalle Digital Breast Tomosynthesis Option

ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DTX-200 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

MAX-IF1000

FDA 510(k)

FDA Class 2 ·Neurology

FLUORCANASITE DENTAL CERAMIC

FDA 510(k)

FDA Class 2 ·Dental

REUSABLE STIMULATING ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PUTMAN STABILIZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DTX-100 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Beltone

FDA UDI

Gn Hearing A/S·05708296200443·PKG,CHGR PREM2,C-1,BT,CFF1,US

Beltone

FDA UDI

Gn Hearing A/S·05708296200603·PKG,CHGR PREM3,C-1,BT,CFF1,GDS

Beltone

FDA UDI

Gn Hearing A/S·05708296200467·PKG,CHGR PREM2,C-1,BT,CFF1,AUS

Beltone

FDA UDI

Gn Hearing A/S·05708296214457·PKG,CHGR PREM3,C-1,BT,CFF1,US

Beltone

FDA UDI

Gn Hearing A/S·05708296200726·PKG,CHGR PREM3,C-1,BT,CFF4,AUS

Beltone

FDA UDI

Gn Hearing A/S·05708296233748·PKG,CHGR PREM3,C-1,BT,CFF4,US

Beltone

FDA UDI

Gn Hearing A/S·05708296200474·PKG,CHGR PREM2,C-1,BT,CFF1,GDS