Registry Insights · PMDA
Japan Medical Device Registry Statistics
Aggregated from 88,166 official PMDA approval records covering 3,461 manufacturers. Data as of 2025-02-19.
The Pharmaceuticals and Medical Devices Agency (PMDA) regulates medical devices in Japan. As of 2025-02-19, this registry snapshot contains 88,166 approval records.
The largest manufacturer by approvals is KSI Corporation with 3,058 approvals.
Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable Japan device database, or see our methodology for how the data is collected.
88,166
Approvals
3,461
Manufacturers
Approvals by Device Category
Largest device category groups among approvals
| Device Category | Approvals | Share |
|---|---|---|
| Joint surgery instrument | 3,411 | 3.9% |
| Bone surgery instrument | 2,398 | 2.7% |
| Spinal surgery instrument | 2,364 | 2.7% |
| Joint surgery instruments | 1,687 | 1.9% |
| Pioneer | 1,087 | 1.2% |
| Instruments for bone surgery | 844 | 1.0% |
| Instruments for spine surgery | 730 | 0.8% |
| Scissors | 627 | 0.7% |
| Operating table accessories | 623 | 0.7% |
| Pincers | 621 | 0.7% |
| Tweezers | 537 | 0.6% |
| Bracelet | 522 | 0.6% |
| Needle holder | 469 | 0.5% |
| Ophthalmic tweezers | 465 | 0.5% |
| Internal fixation plate | 463 | 0.5% |
| Only | 419 | 0.5% |
| Dental implant abutment | 337 | 0.4% |
| Elastic stockings | 327 | 0.4% |
| Pliers | 309 | 0.4% |
| Dental implant surgical instruments | 291 | 0.3% |
Top 50 Manufacturers in Japan
Ranked by approvals. Company names are normalized; affiliated legal entities are listed separately, as registered.
| Rank | Manufacturer | Approvals | Top categories |
|---|---|---|---|
#1 | KSI Corporation | 3,058 | Joint surgery instrument Bone surgery instrument Spinal surgery instrument |
#2 | Dental Medical Co., Ltd. | 1,984 | Dental mirror Dental rubber abrasive Dental laboratory electric engine |
#3 | Tanaka Medical Instrument Manufacturing Co., Ltd. | 1,734 | Bracelet Bone surgery instrument Pioneer |
#4 | Fujiflex Corporation | 1,170 | Spinal surgery instrument Joint surgery instrument Pioneer |
#5 | Manufacture and sales/KSI Co., Ltd. | 1,041 | Joint surgery instruments Instruments for bone surgery Instruments for spine surgery |
#6 | Manufacture and sales/Mizuho Co., Ltd. | 1,025 | Operating table accessories Instruments for spine surgery Pioneer |
#7 | FUJIFILM Corporation | 1,024 | Hand-heldextracorporeal ultrasound probe Superconducting magnet type whole-body MR device Permanent magnet whole-body MR system |
#8 | Olympus Medical Systems Corporation | 926 | Endoscope component adapter Videoflexible colonoscope Video soft gastroduodenoscope |
#9 | Inami Co., Ltd. | 721 | Ophthalmic hook Ophthalmic tweezers Ophthalmic scissors |
#10 | Homs Giken Corporation | 698 | Bone surgery instrument Surgical drill bit guide Surgical screwdriver |
#11 | Roche Diagnostics K.K. | 665 | SARS Coronavirus Antigen Kit Troponin Kit Histological examination tumor marker kit |
#12 | Kyocera Corporation | 639 | Joint surgery instruments Hip prosthesis femoral component Dental implant abutment |
#13 | Manufacture and sales/Senko Medical Industry Co., Ltd. | 588 | Scissors Hook Pliers |
#14 | Manufacturing and sales: R E Medical Corporation | 583 | Ophthalmic tweezers Kushiro for ophthalmology Reusable ophthalmic surgery cannula |
#15 | Muranaka Medical Equipment Co., Ltd. | 582 | Operating Table Accessories Unheated nebulizer Instrument decontamination washer |
#16 | Ario Medical Corporation | 551 | Spinal surgery instrument Joint surgery instrument Bone surgery instrument |
#17 | GE Healthcare Japan K.K. | 537 | High frequency coil for MR equipment Hand-heldextracorporeal ultrasound probe General-purpose ultrasound diagnostic imaging system |
#18 | Japan Medtronic Corporation | 527 | Implantable defibrillator and pacemaker lead Implantable pain relief stimulator Embedded active device programmer |
#19 | Johnson & Johnson Corporation | 525 | Internal fixation plate Bone surgery instrument Intravertebral fusion device |
#20 | Nipro Corporation | 518 | Infusion set for natural fall type and pump connection Single-usefor general veinswinged needle Urokinase-based emergency blood access indwelling catheter |
#21 | Ohmic Corporation | 517 | Spinal surgery instrument Joint surgery instrument Bone surgery instrument |
#22 | Smith & Nephew Corporation | 505 | Joint surgery instrument Bone surgery instrument Ligament and tendon surgery instrument |
#23 | Manufacture and sales/Olympus Medical Systems Corporation | 497 | Rigid resectoscope Parts adapter for endoscope Reusable non-active endoscopic instrument |
#24 | Boston Scientific Japan K.K. | 433 | Implantable defibrillator/pacemaker lead Endocardial implantable pacemaker lead Implantable pain relief stimulator |
#25 | Johnson & Johnson K.K. | 423 | Instruments for spine surgery Joint surgery instruments Spinal fixation device |
#26 | Manufacturing and sales: Covidien Japan K.K. | 411 | Single Use Trocar Sleeve Internalfixationtissuestaple Single-use tracheostomy tube |
#27 | Manufacture and sales/Fujiflex Co., Ltd. | 401 | Pioneer Joint surgery instruments Instruments for bone surgery |
#28 | SunMedix Corporation | 395 | Pincers Scissors Tweezers |
#29 | Manufacturing and sales: MC Medical Corporation | 394 | Breathing circuit set High-frequency treatment active instrument Bone surgery instrument |
#30 | KARL STORZ Endoscopy Japan K.K. | 388 | Endoscope video camera Endoscope sheath Endoscopic video image processor |
#31 | Japan Striker Corporation | 378 | Spinal surgery instrument Internal fixation plate Neurosurgery navigation unit |
#32 | Manufacture and sales/Zimmer Biomet LLC | 377 | Joint surgery instruments Instruments for spine surgery Single-use bone surgery instrument |
#33 | Manufacture and sales / RE Medical Co., Ltd. | 374 | File Reusable eye surgery cannula Ophthalmic surgery spatula |
#34 | Tanaka Medical Instruments Manufacturing Co., Ltd. | 349 | Only Scissors Instruments for bone surgery |
#35 | Envista Japan K.K. | 348 | Dental implant abutment Orthodontic attachment Dental implant surgical instruments |
#36 | Ohmic Co., Ltd. | 343 | Instruments for bone surgery Joint surgery instruments Instruments for spine surgery |
#37 | Manufacture and sales/Fukuda Denshi Co., Ltd. | 342 | Multifunctional ECG Hand-held external ultrasound probe Electrocardiogram cable and lead |
#38 | Manufacture and sale: Terumo Corporation | 341 | Prosthesis for promoting central circulatory endovascular embolization Infusion pump extension tube Central circulatory system guiding endovascular catheter |
#39 | Zimmer Biomet LLC | 338 | Internal fixation plate Total knee prosthesis Internal fixing screws |
#40 | Manufacturing and sales: Mizuho Corporation | 337 | Operating Table Accessories Spinal surgery instrument General-purpose electric operating table |
#41 | Meira Corporation | 331 | Bone surgery instrument Internal fixing screws Ligament and tendon surgery instrument |
#42 | ACTYPower Inc. | 328 | Spinal surgery instrument Joint surgery instrument Bone surgery instrument |
#43 | GC Corporation | 327 | Dental implant abutment Dental implant system Dental adhesive resin cement |
#44 | Medmetalex Corporation | 319 | Joint surgery instrument Spinal surgery instrument Ligament and tendon surgery instrument |
#45 | Manufacturing and sales: Gunze Medical Corporation | 313 | Bone surgery instrument Internal fixation plate Absorbent internal fixing screw |
#46 | Philips Japan Inc. | 312 | High frequency coil for MR equipment Hand-heldextracorporeal ultrasound probe Ventilator mask |
#47 | Jinvy Japan G.K. | 311 | Dental implant surgical instruments Dental implant abutment Spinal surgery instrument |
#48 | Manufacturing and sales: Create Medic Corporation | 302 | Intestinal tube Short-term use bile duct catheter Short-term use gastrostomy feeding tube |
#49 | Manufacturing and sales: Handaya Shoten Co., Ltd. | 295 | Ophthalmic tweezers Reusable ophthalmic cannula Eyelid opener |
#50 | Medtronic Japan Co., Ltd. | 293 | Implantable defibrillator/pacemaker lead Implantable pain relief stimulator Programmer for implantable active devices |
About this data: statistics are computed from the official Pharmaceuticals and Medical Devices Agency registry as mirrored in the Pure Global database (88,166 records, newest registration dated 2025-02-19; page generated 2026-08-05). Company names are normalized for whitespace and case, but distinct legal entities of the same group are counted separately. See methodology.