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 | 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 | Tab Electrode Cable 2m | 2019-11-04 |
| OTODYNAMICS LIMITED | Tab Electrode Cable 1m | 2019-11-04 |
| OTODYNAMICS LIMITED | UGD/UPD Probe Body & Lid (RED) PK 10 | 2019-11-04 |
| OTODYNAMICS LIMITED | UGD/UPD Probe Body & Lid (BLUE) PK 10 | 2019-11-04 |
| OTODYNAMICS LIMITED | UGS/UPS Probe Body & Lid (BLUE) PK 10 | 2019-11-04 |
| OTODYNAMICS LIMITED | UGS/UPS Probe Body & Lid (RED) PK 10 | 2019-11-04 |
| OTODYNAMICS LIMITED | UGD TE+DPOAE Serviceable Probe (BLUE) | 2019-11-04 |
| OTODYNAMICS LIMITED | UGD TE+DPOAE Serviceable Probe (RED) | 2019-11-04 |
| OTODYNAMICS LIMITED | UGS TEOAE Serviceable Probe (BLUE) | 2019-11-04 |
| OTODYNAMICS LIMITED | UGS TEOAE Serviceable Probe (RED) | 2019-11-04 |
| OTODYNAMICS LIMITED | Otoport Binaural ABR Module (Upgrade) | 2019-11-04 |
| OTODYNAMICS LIMITED | Otoport DP Clinical OAE+ABR Analyser | 2019-11-04 |
| OTODYNAMICS LIMITED | Otoport DP Clinical | 2019-11-04 |
| 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 LIMITED | Otoport - ABR Screener | 2018-07-06 |
| OTODYNAMICS LIMITED | Otoport - Screener with ABR | 2018-07-06 |
| OTODYNAMICS LIMITED | Otoport - ABR module (upgrade) | 2018-07-06 |
| OTODYNAMICS LIMITED | ABR Fixing Screw | 2018-07-06 |
| OTODYNAMICS LIMITED | ABR Ear Cups | 2018-07-06 |
| OTODYNAMICS LIMITED | Equipment Case for OAE+ABR Kit | 2018-07-06 |
| OTODYNAMICS LIMITED | ABR Desktop Stand/Crib Carry Crib | 2018-07-06 |
| OTODYNAMICS LIMITED | ABR Infection Control Sleeve | 2018-07-06 |
| OTODYNAMICS LIMITED | ABR Starter Pack | 2018-07-06 |
| OTODYNAMICS LIMITED | Electrode Cable 2m | 2018-07-06 |
| OTODYNAMICS LIMITED | Electrode Cable 1m | 2018-07-06 |
| OTODYNAMICS LIMITED | ABR Test Cavity | 2018-07-06 |
| OTODYNAMICS LIMITED | Otocheck - ABR Screener | 2018-07-06 |
| OTODYNAMICS LIMITED | Otoport - Advance OAE+ABR Analyser | 2018-07-06 |
| OTODYNAMICS LIMITED | Otoport - DP+TE OAE+ABR Analyser | 2018-07-06 |
| OTODYNAMICS LIMITED | Otocheck - DPOAE + ABR Screener | 2018-07-06 |
| OTODYNAMICS LIMITED | Otocheck - TEOAE+ABR Screener | 2018-07-06 |
| OTODYNAMICS LIMITED | Otoport/Otocheck Carry Case with Printer | 2018-03-29 |
| OTODYNAMICS LIMITED | Otoport/Otocheck Carry Case | 2018-03-29 |
| OTODYNAMICS LIMITED | Calibration Unit | 2018-03-29 |
| OTODYNAMICS LIMITED | OAE Test Cavity | 2018-03-29 |
| OTODYNAMICS LIMITED | TE DPOAE Box Sample Box | 2018-03-29 |
| OTODYNAMICS LIMITED | DP Tip Sample Box | 2018-03-29 |
| OTODYNAMICS LIMITED | TE Tip Sample Box | 2018-03-29 |
| OTODYNAMICS LIMITED | Probe Cable Clip | 2018-03-29 |
| OTODYNAMICS LIMITED | Probe Pouch | 2018-03-29 |
| OTODYNAMICS LIMITED | SGD TE+DPOAE General (UGD probe with 8-pin probe a | 2018-03-29 |
| OTODYNAMICS LIMITED | SND TE+DPOAE Newborn (UGD probe with 8-pin probe a | 2018-03-29 |
| OTODYNAMICS LIMITED | SGS TEOAE General (UGS probe with 8-pin probe adap | 2018-03-29 |
| OTODYNAMICS LIMITED | SGS TEOAE General (UGS probe with 5-pin probe adap | 2018-03-29 |
| OTODYNAMICS LIMITED | SNS TEOAE Newborn (UGS probe with 5-pin probe ada | 2018-03-29 |
| OTODYNAMICS LIMITED | SNS TEOAE Newborn (UGS probe with 8-pin probe ada | 2018-03-29 |
| OTODYNAMICS LIMITED | ECP Echocheck General Purpose Probe | 2018-03-29 |
| OTODYNAMICS LIMITED | UGS TEOAE General Purpose Probe | 2018-03-29 |
| OTODYNAMICS LIMITED | UGS TEOAE General Purpose Probe | 2018-03-29 |
| OTODYNAMICS LIMITED | Otoport/Otocheck Docking Station | 2018-03-29 |
| OTODYNAMICS LIMITED | Otoport/Otocheck Charging Cradle | 2018-03-29 |
| OTODYNAMICS LIMITED | Otoport/Otocheck compact wired charger | 2018-03-29 |
| OTODYNAMICS LIMITED | Otoport/Otocheck Infection Control Sleeve | 2018-03-29 |
| OTODYNAMICS LIMITED | Otoport/Otocheck Download Cable | 2018-03-29 |
| OTODYNAMICS LIMITED | Echoport - ILO292 USB-II DPOAE+TEOAE Analyser | 2018-03-29 |
| OTODYNAMICS LIMITED | Echoport - ILO292 USB-I DPOAE+TEOAE Analyser | 2018-03-29 |
| OTODYNAMICS LIMITED | Echoport - ILO288 USB-II DPOAE+TEOAE Analyser | 2018-03-29 |
| OTODYNAMICS LIMITED | Echoport - ILO288 USB-I TEOAE Analyser | 2018-03-29 |
| OTODYNAMICS LIMITED | Otocheck - LE DPOAE Screener | 2018-03-29 |
| OTODYNAMICS LIMITED | Otocheck - LE TEOAE Screener | 2018-03-29 |
| OTODYNAMICS LIMITED | Otoport - Advance OAE Analyser | 2018-03-29 |
| OTODYNAMICS LIMITED | Otoport - DP+TE OAE Analyser | 2018-03-29 |
| OTODYNAMICS LIMITED | Otocheck - DPOAE Screener | 2018-03-29 |
| OTODYNAMICS LIMITED | Otocheck - TEOAE Screener | 2018-03-29 |
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 |