Panin Srl

Manufacturer

🇮🇹 Italy·8 Basic UDI-DIs·8 Devices·BUREAU VERITAS ITALIA S.P.A., ISTITUTO SUPERIORE DI SANITA', KIWA CERMET ITALIA S.P.A., and KIWA CERMET ITALIA S.P.A.

DEVINTEC SAGL

Manufacturer

🇨🇭 Switzerland·4 Basic UDI-DIs·16 Devices·5 Importers·BUREAU VERITAS ITALIA S.P.A., BUREAU VERITAS ITALIA S.P.A., ISTITUTO SUPERIORE DI SANITA', and BUREAU VERITAS ITALIA S.P.A.

MDI Medical Limited

Importer

🇮🇪 Ireland·7 Manufacturers

FBI Medizintechnik GmbH

Importer

🇩🇪 Germany·1 Manufacturer

FIAB SPA, MODELS F7244, F7233, F7234, F7277

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Digistat Smart Central

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cliniview

FDA 510(k)

FDA Class 2 ·Radiology

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

FDA 510(k)

FDA Class 2 ·Orthopedic

ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)

FDA 510(k)

FDA Class 2 ·Orthopedic

E-EEGX, N-EEGX

FDA 510(k)

FDA Class 2 ·Neurology

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE B450

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTIVASCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE B450, E-musb

FDA 510(k)

FDA Class 2 ·Cardiovascular

Steriking® LT-Blueline Pouches with Tyvek®

FDA 510(k)

FDA Class 2 ·General Hospital

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

FDA 510(k)

FDA Class 2 ·Anesthesiology

Icare ic100

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX

FDA 510(k)

FDA Class 2 ·Anesthesiology

Steriking LT-Blueline Pouches with Tyvek

FDA 510(k)

FDA Class 2 ·General Hospital

PLANMED NUANCE DIGIGUIDE

FDA 510(k)

FDA Class 2 ·Radiology