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Sources: EU EUDAMED, US FDA
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Country: Germany
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21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Enforcement
Class II
·Terminated·Ottobock Orthopedic Industrie·February 20, 2019
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Enforcement
Class II
·Terminated·Ottobock Orthopedic Industrie·February 20, 2019
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.
FDA Enforcement
Class II
·Terminated·Hager & Meisinger Gmbh·September 16, 2020
21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Enforcement
Class II
·Terminated·Ottobock Orthopedic Industrie·February 20, 2019
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
FDA Enforcement
Class II
·Terminated·Otto Bock Healthcare GmbH·August 5, 2015
ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·May 16, 2018
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
FDA Enforcement
Class II
·Ongoing·Voco GmbH·February 28, 2024
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
FDA Enforcement
Class II
·Ongoing·Voco GmbH·February 28, 2024
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·June 5, 2019
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
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
FDA Enforcement
Class II
·Terminated·Brainlab AG·November 11, 2015
iRIS EYE GmbH
Importer
🇩🇪 Germany·3 Manufacturers
IMMUCOR Medizinische Diagnostik GmbH
Authorized representative
🇩🇪 Germany·4 Manufacturers·36 Devices
asia-med GmbH
Importer
🇩🇪 Germany·5 Manufacturers
VOSTRA GmbH
Manufacturer
🇩🇪 Germany·4 Basic UDI-DIs·4 Devices·TÜV NORD CERT GmbH, TÜV NORD CERT GmbH, and TÜV NORD CERT GmbH
megro GmbH & Co. KG
Importer
🇩🇪 Germany·8 Manufacturers
Geratherm Medical GERMANY GmbH
Manufacturer
🇩🇪 Germany·20 Basic UDI-DIs·23 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
Caretechion GmbH
Authorized representative
🇩🇪 Germany·158 Manufacturers·1463 Devices
Atlas Medical GmbH
Manufacturer
🇩🇪 Germany·179 Basic UDI-DIs·179 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS
SPIGGLE &THEIS Medizintechnik GmbH
Importer
🇩🇪 Germany·19 Manufacturers