Product code EWD
- Device name
- Protector, Hearing (Insert)
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020296 | ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 | Apothecary Products, Inc. | 2002-06-25 |
| K972923 | SUPER SILIPLUGS EAR PLUGS | Interview Medical Technology Corp. | 1997-10-27 |
| K971517 | SILICONE PUTTY EAR PLUGS | Bentec Medical, Inc. | 1997-06-02 |
| K962292 | HEARSAVER | Emtech Laboratories | 1996-10-29 |
| K960500 | THE VIRTUAL M-332 | Virtual Corp. | 1996-04-03 |
| K945376 | DOC'S PROPLUGS EAR PLUGS | Doc'S Proplugs, Inc. | 1995-11-14 |
| K930203 | MODEL 322 CLINICAL AUDIOMETER | Virtual Corp. | 1993-07-08 |
| K915739 | #903 SILAFLEX II | Flents Products Co., Inc. | 1992-06-30 |
| K910177 | SEAL-RITE SILICONE EAR PLUG | Flents Products Co., Inc. | 1991-06-24 |
| K862045 | DOC'S PROPLUGS EAR PLUGS | Doc'S Proplugs, Inc. | 1987-04-10 |
| K821187 | MEDCO CUSTOM EAR PROTECTOR MOLD KIT | Santa Barbara Medco, Inc. | 1982-05-27 |
| K791608 | BILSOM PROPP | Bilson International, Inc. | 1979-10-10 |
| K781907 | EAR STOPPLES FOR NOISE ATTENTION | Crown Delta Corp. | 1978-11-22 |
| K781491 | PRO-MOLD, CUSTOM EAR | Mcghan Medical Corp. | 1978-09-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10194484320758 | Condor | GRAINGER INTERNATIONAL, INC. | 2024-09-05 |
| 10850015055727 | ULINE REUSABLE EARPLUGS - UNCORDED | ULINE, INC. | 2024-07-25 |
| 10850015055734 | ULINE REUSABLE EARPLUGS - CORDED | ULINE, INC. | 2024-07-25 |
| 10850015055765 | ULINE BELL EARPLUGS - UNCORDED | ULINE, INC. | 2024-07-23 |
| 10850015055772 | ULINE BELL EARPLUGS - CORDED | ULINE, INC. | 2024-07-23 |
| 10850015055758 | ULINE BULLET EARPLUGS - CORDED | ULINE, INC. | 2024-07-23 |
| 10850015055741 | ULINE BULLET EARPLUGS - UNCORDED | ULINE, INC. | 2024-07-23 |
| 10850015055710 | ULINE EARPLUGS IN A BUCKET | ULINE, INC. | 2024-05-13 |
| 10850015055703 | ULINE BULLET EARPLUGS REFILL | ULINE, INC. | 2024-05-13 |
| G599103E0 | Aqua Plus Single Blue 2x8 g | Jkr Laboratories, Inc. | 2024-02-12 |
| 20612479267880 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2023-08-30 |
| 10850015055291 | Uline Bullet Earplugs Refill | ULINE, INC. | 2022-01-24 |
| 00023185000627 | FLENTS PROTECHS | APOTHECARY PRODUCTS, LLC | 2020-10-13 |
| 00023185000504 | Flents | APOTHECARY PRODUCTS, LLC | 2020-09-23 |
| 00023185000269 | Flents | APOTHECARY PRODUCTS, LLC | 2020-09-23 |
| 00023185000191 | Flents | APOTHECARY PRODUCTS, LLC | 2020-09-23 |
| 00023185000122 | Flents | APOTHECARY PRODUCTS, LLC | 2020-09-23 |
| 00023185000061 | Flents | APOTHECARY PRODUCTS, LLC | 2020-09-16 |
| 00023185002652 | EZY DOSE KIDS | APOTHECARY PRODUCTS, LLC | 2020-09-11 |
| 00023185002041 | Acu-Life | APOTHECARY PRODUCTS, LLC | 2020-09-10 |
| 00023185000597 | Flents Protechs | APOTHECARY PRODUCTS, LLC | 2020-08-12 |
| 00023185000603 | Flents Protechs | APOTHECARY PRODUCTS, LLC | 2020-08-12 |
| 00023185000610 | Flents Protechs | APOTHECARY PRODUCTS, LLC | 2020-08-12 |
| 00023185001891 | REXALL | APOTHECARY PRODUCTS, LLC | 2020-07-15 |
| 10851253007585 | Uline Bell Earplugs - Corded | ULINE, INC. | 2019-02-07 |
| 10851253007578 | Uline Bell Earplugs - Uncorded | ULINE, INC. | 2019-02-07 |
| 10851253007530 | Uline Reusable Earplugs - Corded | ULINE, INC. | 2019-02-07 |
| 10851253007523 | Uline Reusable Earplugs - Uncorded | ULINE, INC. | 2019-02-07 |
| 10851253007493 | Uline Bullet Earplugs - Corded | ULINE, INC. | 2019-02-07 |
| 10851253007486 | Uline Bullet Earplugs - Uncorded | ULINE, INC. | 2019-02-07 |