Panels › General, Plastic Surgery › Product code JEA · Class 1
Table, Surgical With Orthopedic Accessories, Ac-Powered
Regulation 878.4960
0510(k)s in 12 months (10 all time)
0recalls in 12 months (41 all time)
1recalls that name a 510(k)
Top companies in JEA
| Company | 510(k)s | Recalls |
|---|---|---|
| Trumpf Medical Systems | 0 | 20 |
| Baxter Healthcare Corporation | 0 | 14 |
| Andronic Devices, Ltd. | 4 | 0 |
| Mizuho Orthopedic Systems Inc | 0 | 3 |
| Mizuho OSI | 0 | 2 |
| Orthopedic Systems, Inc. | 2 | 0 |
| Steris Corporation | 0 | 2 |
| M.D. Intl., Inc. | 1 | 0 |
| Mend Technologies, Inc. | 1 | 0 |
| Skytron, Div. the Kmw Group, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 1995 | K953071 | STRYKER COMMAND2 OFFICE CONSOLE Stryker Instruments | JEA |
| Mar 30, 1993 | K924094 | MEND APC Mend Technologies, Inc. | JEA |
| May 21, 1991 | K910736 | JACKSON MULTIPURPOSE OPERATING TABLE Orthopedic Systems, Inc. | JEA |
| Apr 29, 1991 | K911522 | ARTHROBOT(TM) WRIST HOLDER ACCESSORY Andronic Devices, Ltd., CA | JEA |
| Feb 20, 1990 | K900290 | SKYTRON MODEL 1100 AND MODEL 142 Skytron, Div. the Kmw Group, Inc. | JEA |
| Aug 29, 1989 | K894789 | DMI 250 SERIES POWER SURGERY TABLE M.D. Intl., Inc. | JEA |
| Mar 25, 1988 | K881060 | OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) Orthopedic Systems, Inc. | JEA |
| Dec 10, 1987 | K874762 | ARTHROTRACT UPPER LIMB TRACTION ACCESSORY Andronic Devices, Ltd., CA | JEA |
| Nov 25, 1987 | K873080 | ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY Andronic Devices, Ltd., CA | JEA |
| Nov 25, 1987 | K873079 | ARTHROBOT 100 UPPER LIMB POSITIONER Andronic Devices, Ltd., CA | JEA |
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