47 results
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23ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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Siemens Healthcare GmbH
Authorized representative
🇩🇪 Germany·8 Manufacturers
Woodway GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer·2 Devices
LoveOptic GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer
Impulse Dynamics
Authorized representative
🇩🇪 Germany·1 Manufacturer
3M Deutschland GmbH (Medical)
Authorized representative
🇩🇪 Germany·3 Manufacturers
MEyeTech GmbH
Importer
🇩🇪 Germany·8 Manufacturers
MedDevConsult GmbH
Authorized representative
🇩🇪 Germany·8 Manufacturers·14 Devices
Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
FDA Enforcement
Class II
·Terminated·LivaNova Deutschland GmbH·July 8, 2020
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
FDA Enforcement
Class II
·Terminated·LivaNova Deutschland GmbH·July 8, 2020
Velamed GmbH
Importer
🇩🇪 Germany·1 Manufacturer
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
FDA Enforcement
Class II
·Ongoing·HUMAN MED AG·March 12, 2025
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·December 4, 2019
Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 23, 2020
Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 23, 2020
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
FDA Enforcement
Class II
·Terminated·Abbott GmBH & Co. KG·December 4, 2019
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
FDA Enforcement
Class II
·Ongoing·Macherey Nagel Gmbh & Co. Kg·May 22, 2024
ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED
FDA Enforcement
Class II
·Terminated·Brainlab AG·May 7, 2014