24 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
Linde GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer
Linde Gas Therapeutics GmbH
Importer
🇩🇪 Germany
Velamed GmbH
Importer
🇩🇪 Germany·1 Manufacturer
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
Siemens Healthineers AG
Importer
🇩🇪 Germany·20 Manufacturers
Siemens Healthcare GmbH
Importer
🇩🇪 Germany·20 Manufacturers
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
MEyeTech GmbH
Importer
🇩🇪 Germany·8 Manufacturers
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
Uniprox GmbH & Co.KG
Importer
🇩🇪 Germany·11 Manufacturers
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
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.
FDA Enforcement
Class II
·Terminated·WOM World of Medicine AG·December 5, 2018