23 results
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41ms
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Sources: EU EUDAMED, US FDA
SQ PRODUCTS AG
FDA registration
SQ PRODUCTS AG·10 products·🇨🇭 Switzerland
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer
🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH
Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer
🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 26, 2019
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339
FDA Enforcement
Class II
·Terminated·Nobel Biocare Procera LLC·June 2, 2021
M.I.Tech Co., Ltd
Manufacturer
🇰🇷 South Korea·809 Basic UDI-DIs·809 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer
🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS
Coltène/Whaledent GmbH +Co. KG
Importer
🇩🇪 Germany·6 Manufacturers
Medical Mix
Importer
🇪🇸 Spain·6 Manufacturers
Van Hopplynus Ophtalm NV
Importer
🇧🇪 Belgium·16 Manufacturers
Sirona Dental Systems GmbH
Importer
🇩🇪 Germany·7 Manufacturers
W.M.BLOSS, S.A
Importer
🇪🇸 Spain·20 Manufacturers
Rockmed BV
Importer
🇳🇱 Netherlands·18 Manufacturers
Polytech Domilens GmbH
Importer
🇩🇪 Germany·13 Manufacturers
Vingmed AB
Importer
🇸🇪 Sweden·25 Manufacturers
American Dental Systems GmbH
Importer
🇩🇪 Germany·37 Manufacturers
Arseus Medical Group nv
Importer
🇧🇪 Belgium·69 Manufacturers
Plandent Oy
Importer
🇫🇮 Finland·43 Manufacturers