| 130715 | 00821925014480 | Gyrus ACMI, Inc. | Class IIa | |
| 130716 | 00821925017436 | Gyrus ACMI, Inc. | Class IIa | |
| 130725 | 00821925028180 | Gyrus ACMI, Inc. | Class IIa | |
| 130726 | 00821925017481 | Gyrus ACMI, Inc. | Class IIa | |
| 130783 | 00821925017801 | Gyrus ACMI, Inc. | Class IIa | |
| 130785 | 00821925017818 | Gyrus ACMI, Inc. | Class IIa | |
| 130787 | 00821925017825 | Gyrus ACMI, Inc. | Class IIa | |
| 130789 | 00821925015876 | Gyrus ACMI, Inc. | Class IIa | |
| 130915 | 00821925016682 | Gyrus ACMI, Inc. | Class IIa | |
| 130916 | 00821925016699 | Gyrus ACMI, Inc. | Class IIa | |
| 70130717 | 00821925024540 | Gyrus ACMI, Inc. | Class IIa | |
| 70130790 | 00821925028449 | Gyrus ACMI, Inc. | Class IIa | |
| 70130791 | 00821925028456 | Gyrus ACMI, Inc. | Class IIa | |
| 70130791 | 00821925033719 | Gyrus ACMI, Inc. | Class IIa | |
| 890205 | 00821925022034 | Gyrus ACMI, Inc. | Class IIa | |
| 890206 | 00821925022041 | Gyrus ACMI, Inc. | Class IIa | |
| Alzalingua | 08057204610032 | E.P. Medica S.r.l. | Class I | |
| Auricular speculum | 05605622070155 | Bastos Viegas s.a. | Class I | |
| Auricular speculum | 05605622232942 | Bastos Viegas s.a. | Class I | |
| Bite Blocks | 06942231631100 | Jiangsu Kangjin Medical Instrument Co., Ltd. | Class I | |
| Cochlear® Conical guide drill 3+4mm | 09321502026505 | Cochlear Bone Anchored Solutions AB | Class IIa | |
| Cochlear® Widening drill 3mm w countersink | 09321502019613 | Cochlear Bone Anchored Solutions AB | Class IIa | |
| Curved Sucker Fine End (shallow 50°) | 05060180258252 | Exmoor Plastics Limited | Class IIa | |
| Davis Boyle Mouth Gags - Adult | 05060417201211 | Sheffmed Limited | Class Is | |
| Davis Boyle Mouth Gags - Child | 05060417201204 | Sheffmed Limited | Class Is | |
| DILATLAX® - Balloon Dilation System | 08056209010007 | BenCorpp Srl | Class Is | |
| DILATLAX® - Balloon Dilation System | 08056209010014 | BenCorpp Srl | Class Is | |
| DILATLAX® - Balloon Dilation System | 08056209010021 | BenCorpp Srl | Class Is | |
| DILATLAX® - Balloon Dilation System | 08056209010038 | BenCorpp Srl | Class Is | |
| DILATLAX® - Balloon Dilation System | 08056209010045 | BenCorpp Srl | Class Is | |
| DILATLAX® - Balloon Dilation System | 08056209010052 | BenCorpp Srl | Class Is | |
| DILATLAX® - Balloon Dilation System | 08056209010069 | BenCorpp Srl | Class Is | |
| Disposable Mouth guard | 06942231651207 | Jiangsu Kangjin Medical Instrument Co., Ltd. | Class Is | |
| Disposable Mouth guard | 06942231651252 | Jiangsu Kangjin Medical Instrument Co., Ltd. | Class Is | |
| Draffin Bipod (pair) | 05060417201419 | Sheffmed Limited | Class Is | |
| Draffin Bipod (pair) Short | 05060417201426 | Sheffmed Limited | Class Is | |
| Ear Curette - Jobson Horne Probe | 09421901970468 | Adept Medical Ltd | Class Is | |
| Ear Curette -Oval Jobson Horne Probe | 09421901970819 | Adept Medical Ltd | Class Is | |
| Ear Suction Controller | 09421902825101 | Adept Medical Ltd | Class Is | |
| Fine End 18G Non-Sterile | 05060417204595 | Sheffmed Limited | Class I | |
| Guide drill, 3-4mm | 05712149000326 | Oticon Medical AB | Class IIa | |
| Gwynne Evans Dissector 200 x 6mm | 05060417201594 | Sheffmed Limited | Class Is | |
| Healing cap | 05712149002757 | Oticon Medical AB | Class Is | |
| Inflation Devices and Accessories | 04250676734495 | SPIGGLE & THEIS Medizintechnik GmbH | Class Is | |
| Inflation Devices and Accessories | 04250676746658 | SPIGGLE & THEIS Medizintechnik GmbH | Class Is | |
| Insertion Electrode Compressed | 09008737082581 | MED-EL Elektromedizinische Geräte GmbH | Class IIa | |
| Insertion Electrode FLEX24 | 09008737082574 | MED-EL Elektromedizinische Geräte GmbH | Class IIa | |
| Insertion Electrode FLEX26 | 09008737366339 | MED-EL Elektromedizinische Geräte GmbH | Class IIa | |
| Insertion Electrode FLEX28 | 09008737083489 | MED-EL Elektromedizinische Geräte GmbH | Class IIa | |
| Insertion Electrode FLEX34 | 09008737416218 | MED-EL Elektromedizinische Geräte GmbH | Class IIa | |