Focus&Fusion Healthcare (Hangzhou) Co., Ltd

Manufacturer

🇨🇳 China·8 Basic UDI-DIs·87 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Innoventa Medica ApS

Manufacturer

🇩🇰 Denmark·3 Basic UDI-DIs·8 Devices·Intertek Medical Notified Body AB, Intertek Medical Notified Body AB, and Intertek Medical Notified Body AB

LSM-MED S.r.l.

Manufacturer

🇸🇲 San Marino·1 Basic UDI-DI·3 Devices·2 Importers·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

ANGIOLOGICA B.M. S.R.L.

Manufacturer

🇮🇹 Italy·3 Basic UDI-DIs·3 Devices·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

Shanghai HeartCare Medical Technology Corporation Limited

Manufacturer

🇨🇳 China·1 Basic UDI-DI·4 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and UDEM Adriatic d.o.o.

Cutera, Inc.

Manufacturer

🇺🇸 United States·17 Basic UDI-DIs·21 Devices·2 Importers·TUV NORD Polska Sp. z o.o and TÜV NORD CERT GmbH

Fimet Oy

Manufacturer

🇫🇮 Finland·8 Basic UDI-DIs·15 Devices·SGS FIMKO OY and SGS FIMKO OY

Taewoong Medical Co., Ltd.

Manufacturer

🇰🇷 South Korea·236 Basic UDI-DIs·236 Devices·17 Importers·SGS Belgium NV and SGS Belgium NV

Radiant Innovation Inc.

Manufacturer

🇹🇼 Taiwan·19 Basic UDI-DIs·47 Devices·1 Importer·SGS Belgium NV and SGS Belgium NV

Shenzhen Hawk Medical Instrument Co., Ltd.

Manufacturer

🇨🇳 China·15 Basic UDI-DIs·23 Devices·4 Importers·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Lombard Medical Limited

Manufacturer

499 Basic UDI-DIs·499 Devices·4 Importers·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

Eyenuk, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·Intertek Medical Notified Body AB and INTERTEK SEMKO AB

Perflow Medical Ltd.

Manufacturer

🇮🇱 Israel·5 Importers·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

CGI Suomi Oy

Manufacturer

🇫🇮 Finland·5 Basic UDI-DIs·5 Devices·Eurofins Electric & Electronics Finland Oy and Eurofins Electric & Electronics Finland Oy

FOTONA, proizvodnja optoelektronskih naprav d.o.o.

Manufacturer

🇸🇮 Slovenia·6 Basic UDI-DIs·8 Devices·3EC International a.s. and TÜV SÜD Product Service GmbH

Cavex Holland BV

Manufacturer

🇳🇱 Netherlands·33 Basic UDI-DIs·99 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Empatica S.r.L.

Manufacturer

🇮🇹 Italy·1 Basic UDI-DI·1 Device·TUV Rheinland Italia SRL and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

Ziehm Imaging GmbH

Manufacturer

🇩🇪 Germany·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Route 92 Medical, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·1 Importer·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH