ClearanceBrief
Panels › Ear, Nose, Throat › Product code ETD · Class 2

Tube, Tympanostomy

Regulation 874.3880

1510(k)s in 12 months (116 all time)
0recalls in 12 months (14 all time)
11recalls that name a 510(k)
Get daily alerts for ETDSample briefCSV

Top companies in ETD

Company510(k)sRecalls
Exmoor Plastics , Ltd.160
Xomed, Inc.130
Adept Medical, Ltd.18
Treace Medical, Inc.90
Grace Medical, Inc.50
Micromed Development Corp.50
Preceptis Medical50
Richard'S Medical Equip., Inc.40
Richards Medical Co., Inc.40
Mednet Locator, Inc.30
DateFirm and productCodeLinked 510(k)
Jan 17, 2025Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Open, Classified		 ETDK061058
Jan 17, 2025Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Open, Classified		 ETDK061058
Jan 17, 2025Adept Medical Ltd
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Open, Classified		 ETDK061058
Jan 17, 2025Adept Medical Ltd
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Open, Classified		 ETDK061058
Jan 17, 2025Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Open, Classified		 ETDK061058
Jan 17, 2025Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Open, Classified		 ETDK061058
Jan 17, 2025Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Open, Classified		 ETDNone listed
Jan 17, 2025Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Open, Classified		 ETDK061058
Dec 19, 2024Olympus Corporation of the Americas
Duravent Silicone Ventilation Tube. Model Number: 240075.
Open, Classified		 ETDK932166
Feb 7, 2024Olympus Corporation of the Americas
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Open, Classified		 ETDK932166
Jun 9, 2014Summit Medical, Inc.
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 mem
Terminated		 ETDK830228
Nov 20, 2012Gyrus Acmi, Incorporated
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Terminated		 ETDNone listed
Nov 18, 2010Micromedics, Inc.
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.
Terminated		 ETDNone listed
Mar 4, 2010Gyrus ACMI Corporation
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 draina
Terminated		 ETDK820362

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.