This page includes the latest FDA filings for Otodynamics L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 8021990 | ||||||||||
| FEI Number | 2939 | ||||||||||
| Name | OTODYNAMICS, LTD. | ||||||||||
| Owner & Operator | OTODYNAMICS, LTD. | ||||||||||
| Contact Address | 32-34 BEACONSFIELD RD. -- HATFIELD, HERTS GB-NOTA AL10 8BB GB | ||||||||||
| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||||||
| Initial Importer | N | ||||||||||
| Registration Expiration | 2020-04-25 | ||||||||||
| Registration Address | 30-38 BEACONSFIELD RD. HATFIELD, HERTS Hertfordshire, AL10 8BB GB | ||||||||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| OTODYNAMICS LIMITED | OtoNova Pro Infection Control Sleeve | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Fabric Carry Case | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Clinical+AABR | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Clinical | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Clinical+TE | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro User Manual | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Clinical+TE+AABR | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Screener DP+TE+AABR | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Screener DP+AABR | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Screener TE+AABR | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Screener DP+TE | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Screener AABR | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Screener DP | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Screener TE | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Case Service Kit | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Charger PCB Service Kit | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro Main PCB Service Kit | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Pro OAE+AABR instrument | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Battery Assembly Service Kit | 2024-08-28 |
| OTODYNAMICS LIMITED | ABR Electrode Cable (TAB) for OtoNova Pro | 2024-08-28 |
| OTODYNAMICS LIMITED | ABR Electrode Cable (SNAP) for OtoNova Pro | 2024-08-28 |
| OTODYNAMICS LIMITED | XPD Ear Probe | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Wireless Charging Pad | 2024-08-28 |
| OTODYNAMICS LIMITED | OtoNova Charger | 2024-08-28 |
| OTODYNAMICS LIMITED | Tablet Computer for OtoNova Pro | 2024-08-28 |
| OTODYNAMICS LIMITED | Crib/bassinet device holster for OtoNova | 2024-08-28 |
| OTODYNAMICS LIMITED | Otoport Pro Case service kit | 2024-07-26 |
| OTODYNAMICS LIMITED | Red/Blue (Right/Left ear) ID labels/sleeves for XPD probe | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Barcode Module & Flexi service kit | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Display Window service item | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Battery Assembly Service Kit | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Case service kit (Barcode) | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Main PCB Assembly, service item | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Keypad PCB Assembly, service kit | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Analogue Front End PCB Service Kit | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Connector PCB Assembly Service Kit | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro LCD Service Kit | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro User Manual - English | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro AABR instrument | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro OAE instrument | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Infection Control Sleeve | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Docking Station | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport V2/Pro Fabric Case (with Printer compartment) | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport V2/Pro Fabric Carry Case | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Mini Printer V2 package | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Charger V2 | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Advanced Clinical+AABR | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Advanced Clinical | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Clinical+TE+AABR | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Clinical+AABR | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Clinical+TE | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Clinical | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Screener DP+TE+AABR | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Screener TE+AABR | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Screener DP+AABR | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Screener AABR | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Screener DP+TE | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Screener TE | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro Screener DP | 2024-07-25 |
| OTODYNAMICS LIMITED | Otoport Pro OAE+AABR instrument | 2024-07-25 |
| OTODYNAMICS LIMITED | ABR Electrode Cable V2 (NHSP) for Otoport V2/Pro | 2024-07-25 |
| OTODYNAMICS LIMITED | ABR Electrode Cable V2 (TAB) for Otoport V2/Pro | 2024-07-25 |
| OTODYNAMICS LIMITED | ABR Electrode Cable V2 (SNAP) for Otoport V2/Pro | 2024-07-25 |
| OTODYNAMICS LIMITED | Red/Blue ID Labels (Right/Left ear) 2-pair | 2023-05-15 |
| OTODYNAMICS LIMITED | ABR OAE Probe Interface PCB service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | Otoport/Otocheck Case service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | Otoport Keypad PCB Assembly | 2023-05-15 |
| OTODYNAMICS LIMITED | Otoport Battery Assembly service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | Otoport Analogue PCB service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | Otoport LCD service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | Otoport Connector PCB Assembly service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | Otoport Keypad Mat | 2023-05-15 |
| OTODYNAMICS LIMITED | Otoport Main PCB Assembly | 2023-05-15 |
| OTODYNAMICS LIMITED | Otocheck LE Case service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | Otoport LCD Window Bezel | 2023-05-15 |
| OTODYNAMICS LIMITED | Echoport Socket & Loom Assembly | 2023-05-15 |
| OTODYNAMICS LIMITED | Echoport Main PCB | 2023-05-15 |
| OTODYNAMICS LIMITED | Echoport Case service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | Echoport USB Amplifier PCB | 2023-05-15 |
| OTODYNAMICS LIMITED | ABR Case service kit – latch non locking | 2023-05-15 |
| OTODYNAMICS LIMITED | ABR Case service kit – latch locking | 2023-05-15 |
| OTODYNAMICS LIMITED | ABR Feedthrough PCB service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | ABR Case service kit - Top | 2023-05-15 |
| OTODYNAMICS LIMITED | ABR Case service kit - Bottom | 2023-05-15 |
| OTODYNAMICS LIMITED | ABR Amplifier & Control service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | ABR PSU PCB service kit | 2023-05-15 |
| OTODYNAMICS LIMITED | Tip Sample Box (Neonate) | 2023-04-10 |
| OTODYNAMICS LIMITED | Tip Sample Box (General) | 2023-04-10 |
| OTODYNAMICS LIMITED | General Tip Holder for X-series Probes PK25 | 2023-04-10 |
| OTODYNAMICS LIMITED | Neonate Tip Holder for X-series Probes PK25 | 2023-04-10 |
| OTODYNAMICS LIMITED | N6.5B Tips PK100 | 2023-04-10 |
| OTODYNAMICS LIMITED | N5.5B Tips PK100 | 2023-04-10 |
| OTODYNAMICS LIMITED | N5C Tips PK100 | 2023-04-10 |
| OTODYNAMICS LIMITED | N4.5C Tips PK100 | 2023-04-10 |
| OTODYNAMICS LIMITED | N4C Tips PK100 | 2023-04-10 |
| OTODYNAMICS LIMITED | N3.6C Tips PK100 | 2023-04-10 |
| OTODYNAMICS LIMITED | XGD Probe | 2023-04-10 |
| OTODYNAMICS LIMITED | Otoport ABR Binaural Upgrade Kit (DP) | 2019-11-04 |
| OTODYNAMICS LIMITED | Otoport ABR Binaural Upgrade Kit (TE) | 2019-11-04 |
| OTODYNAMICS LIMITED | Otoport/Otocheck Download Cable (Locking) | 2019-11-04 |
OTODYNAMICS, LTD. | Otoport/Otocheck | 2016-08-08 |
OTODYNAMICS, LTD. | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit | 2015-02-23 |
OTODYNAMICS, LTD. | OTODYNAMICS OTOPORT | 2007-11-13 |
OTODYNAMICS, LTD. | Otoport | 2002-01-14 |
OTODYNAMICS, LTD. | Otocheck | 2002-01-14 |
OTODYNAMICS, LTD. | ILO292 Echoport USB | 2002-01-14 |
OTODYNAMICS, LTD. | ILO288 Echoport USB | 2002-01-14 |
OTODYNAMICS, LTD. | ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK | 1998-12-11 |
OTODYNAMICS, LTD. | ILO292 DP ECHOPORT PLUS OAE SYSTEM | 1998-12-11 |
OTODYNAMICS, LTD. | ILO292 DP ECHOPORT PLUS OAE SYSTEM | 1998-12-11 |
OTODYNAMICS, LTD. | ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC | 1997-01-10 |
| NCAGE Code | KB828 | OTODYNAMICS LTD |
| CAGE Code | KB828 | OTODYNAMICS LTD |