Microbrush International

Manufacturer

🇺🇸 United States·9 Basic UDI-DIs·52 Devices

Jiangsu Jumao X-Care Medical Equipment Co.,Ltd.

Manufacturer

🇨🇳 China

MEDPLUS INC.

Manufacturer

🇨🇳 China·TÜV Rheinland LGA Products GmbH

Saria Mehr Co.Ltd

Manufacturer

🇮🇷 Iran·14 Basic UDI-DIs·14 Devices·MTIC InterCert S.r.l. and MTIC InterCert S.r.l.

Medical Computer Systems Ltd.

Manufacturer

🇷🇺 Russian Federation·2 Importers

SHANGHAI ZJ BIO-TECH CO., LTD

Manufacturer

🇨🇳 China·297 Basic UDI-DIs·326 Devices·2 Importers·TÜV Rheinland LGA Products GmbH

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Manufacturer

🇨🇳 China·192 Basic UDI-DIs·192 Devices·1 Importer·CeCert Sp. z o.o.

Ostique Limited

Manufacturer

1 Basic UDI-DI·2 Devices

SWISS PHARMA DYNAMIC LTD Zweigniederlassung

Manufacturer

🇨🇭 Switzerland·1 Basic UDI-DI·1 Device·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

Dyaco international Inc.

Manufacturer

🇹🇼 Taiwan

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

Manufacturer

🇨🇳 China·23 Basic UDI-DIs·23 Devices

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ORIGEN EL ICD: D050, D051, D052, D053 INOGEN EL ICD: D140, D141, D142,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4;

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN, INOGEN, ORIGEN, AUTOGEN EL ICD; DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD; INCEPTA, ENERGEN, PUNCTUA ICD; MOME

Cd-R, Cd-Rw Recorder

FDA classification

FDA Not Classified ·Cd-R, Cd-Rw Recorder

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·VISIAN ICL (IMPLANTABLE COLLAMER LENS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR/S VR,XT DR, XT VR ICD; ENTRUST; INTRINSIC 30 & INTRINSIC ICD; MARQUIS DR, VR ICD; MAXIMO DR, II, VR ICD; PROT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI, Cobalt XT MRI, Crome MRI ICD, Crome MRI ICD,Evera MRI DF-1,Evera MRI DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Defibrillator (S-ICD) EMBLEM MRI, S-ICD Gen 2.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MARQUIS ICD/MAXIMO/MAXIMO II/INTRINSIC/ENTRUST/VIRTUOSO/SECURA ICD FAMILIES