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Sources: EU EUDAMED, US FDA
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ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
FDA Recall
Open, Classified
·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·February 25, 2022
Access BR Monitor, Part No. 387620
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MOI·April 13, 2017
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Terminated
·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·May 14, 2021
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
FDA Recall
Terminated
·Micro-Tech Usa·Product code MND·October 5, 2020
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
FDA Recall
Terminated
·Gyrus Acmi, Incorporated·Product code ETD·October 17, 2012
Duravent Silicone Ventilation Tube. Model Number: 240075.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code ETD·November 19, 2024
Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.
FDA Recall
Terminated
·Summit Medical, Inc.·Product code ETD·May 12, 2014
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear.
FDA Recall
Terminated
·Gyrus ACMI Corporation·Product code ETD·January 8, 2010
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code ETD·December 11, 2023
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab, 1.14 mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0204-01 Otological Ventilation Tubes, Catalog Number VT-0204-01, Shepard, 1.0 mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0406-01 Otological Ventilation Tubes, Catalog Number VT-0406-01, T-Tube, 5mm x 4mm x 1.14mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-01 Otological Ventilation Tubes, Catalog Number VT-0503-01, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-50 Otological Ventilation Tubes, Catalog Number VT-0503-50, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0507-01 Otological Ventilation Tubes, Catalog Number VT-0507-01, Armstrong Grommet w/wire, 1.14mm Lumen, FL, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT0508-50 Otological Ventilation Tubes, Catalog Number VT-0508-50, Modified Armstrong Grommet 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1002-50 Otological Ventilation Tubes, Catalog Number VT-1002-50, Collar Button, 1.27mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1035-01 Otological Ventilation Tubes, Catalog Number VT-1035-01, Collar Button, 1.5mm Lumen, Titanium, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT1204-01 Otological Ventilation Tubes, Catalog Number VT-1204-01, Reuter Bobbin 1.14mm , Lumen, FL Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1421-01 Otological Ventilation Tubes, Catalog Number VT-1421-01, Angled Tab Bobbin 1.27mm Lumen, TI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. ET-ABGDT-45 Distributed By API Anthony products, Inc., ET-ABGDT-45 Armstrong Grommet, 1.14mm Lumen, FP Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-GTST-45-12, Distributed By API Anthony products, Inc., ET-GTST-45-12, T-tube 12 x 10, 1.14mm Lumen, SI , Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-SPDT-40T, Distributed By API Anthony products, Inc., ET-SPDT-40T Shea Parasol w/Tab, 1.0mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-TBDT-45 Distributed By API Anthony products, Inc., ET-TBDT-45 Reuter Bobbin w/c Holes 1.14mm Lumen, FP, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes.
FDA Recall
Terminated
·Micromedics, Inc.·Product code ETD·March 15, 2010
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators
FDA Recall
Open, Classified
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·May 10, 2023
CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators
FDA Recall
Open, Classified
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·May 10, 2023