ETHICON, Inc.
FDA 510(k) & PMA Approved 기기 — 29 products
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총 기기 수29
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최신 FDA 결정
| 유형 | 번호 | 기기명 | 코드 | 날짜 | 작업 |
|---|---|---|---|---|---|
| 510(k) | K253394 | Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture | GAM | 2026-06-25 | 보기 |
| 510(k) | K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | NEW | 2026-05-18 | 보기 |
| 510(k) | K253572 | STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device | GAW | 2026-03-27 | 보기 |
| 510(k) | K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | GAM | 2026-02-06 | 보기 |
| 510(k) | K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | GAM | 2025-12-22 | 보기 |
| 510(k) | K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | NEW | 2025-11-12 | 보기 |
| 510(k) | K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | GAM | 2022-11-15 | 보기 |
| 510(k) | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | 2022-02-22 | 보기 |
| 510(k) | K213512 | DERMABOND PRINEO Skin Closure System | OMD | 2021-12-07 | 보기 |
| 510(k) | K201996 | Monocryl Plus Antibacterial Suture | GAM | 2020-12-21 | 보기 |
| 510(k) | K201686 | GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide | OTN | 2020-09-17 | 보기 |
| 510(k) | K201143 | VICRYL Mesh | FTL | 2020-08-06 | 보기 |
| 510(k) | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | NEW | 2020-03-25 | 보기 |
| 510(k) | K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | GAM | 2019-12-18 | 보기 |
| 510(k) | K191373 | VICRYL Mesh | FTL | 2019-10-22 | 보기 |
| 510(k) | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | 2019-06-27 | 보기 |
| 510(k) | K182873 | STRATAFIX 대칭 PDS Plus 노트리스 조직 통제 장치, STRATAFIX 스플라이얼 PDS Plus 노트리스 조직 통제 장치, STRATAFIX 스플라이얼 MONOCRYL Plus 노트리스 조직 통제 장치, STRATAFIX 스플라이얼 MONOCRYL 노트리스 조직 통제 장치 | NEW | 2019-01-10 | 보기 |
| 510(k) | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | 2018-09-28 | 보기 |
| 510(k) | K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | PWJ | 2018-08-10 | 보기 |
| 510(k) | K173923 | Temporary Cardiac Pacing Wire | LDF | 2018-08-02 | 보기 |
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