Company ยท US
Dyonics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1990. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRX | Arthroscope | 8 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | 3 |
| BWN | Table And Attachments, Operating-Room | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| HST | Apparatus, Traction, Non-Powered | 1 |
| HTR | Rasp | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| LXI | Guide, Drill, Ligament | 1 |
| LYH | Arthrometer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 16, 1990 | K900070 | MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM Dyonics, Inc. | HRX |
| Jan 2, 1990 | K896416 | DYONICS SHOULDER PORTAL SYSTEM Dyonics, Inc. | HRX |
| Dec 14, 1989 | K893136 | SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY Dyonics, Inc. | HRX |
| Nov 3, 1989 | K890665 | MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES Dyonics, Inc. | HRX |
| Aug 18, 1989 | K894728 | DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE Dyonics, Inc. | HRX |
| Jun 23, 1989 | K892062 | PS3500 ARTHROSCOPIC SURGICAL SYSTEM Dyonics, Inc. | HRX |
| Dec 7, 1988 | K884839 | MODIFIED SAW BLADES TO THE SAGITAL SAW Dyonics, Inc. | KIJ |
| Nov 17, 1988 | K881876 | DYNAMIC CRUCIATE TESTER Dyonics, Inc. | LYH |
| Mar 21, 1988 | K880739 | DYONICS DRILL GUIDE/ISOMETER SYSTEM Dyonics, Inc. | LXI |
| Mar 4, 1988 | K880150 | PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM Dyonics, Inc. | HWE |
| Feb 20, 1987 | K870212 | ARTHROSCOPIC SHOULDER HOLDER Dyonics, Inc. | HST |
| Dec 15, 1986 | K862017 | ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT Dyonics, Inc. | HRX |
| Sep 7, 1984 | K843121 | GUIDE TO THE KNEE Dyonics, Inc. | BWN |
| Feb 27, 1984 | K833943 | MENISCAL SUTURING SYSTEM Dyonics, Inc. | LXH |
| Nov 14, 1983 | K833587 | DISPOSABLE ARTHROSCOPY BLADE Dyonics, Inc. | HRX |
| May 7, 1982 | K820367 | INTRA-ARTICULAR SURGICAL SYSTEM Dyonics, Inc. | KIJ |
| Sep 24, 1981 | K812506 | THE ARTHROFILE Dyonics, Inc. | HTR |
| Apr 5, 1979 | K790502 | DYONICS STEROTOXIC POSITIONER Dyonics, Inc. | HAW |
| Feb 1, 1978 | K771218 | INTRA-ARTICULAR SHAVER Dyonics, Inc. | KIJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||