Panels › General Hospital › Product code FMJ · Class 2
Manometer, Spinal-Fluid
Regulation 880.2500
0510(k)s in 12 months (6 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in FMJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Smiths Medical ASD, Inc. | 0 | 4 |
| Busse Hospital Disposables, Inc. | 1 | 1 |
| Ansr Ent., Inc. | 1 | 0 |
| B.Braun Medical, Inc. | 1 | 0 |
| Megadyne Medical Products, Inc. | 1 | 0 |
| PAJUNK GmbH Medizintechnologie | 1 | 0 |
| Smiths Industries Medical Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 2017 | K170305 | Spinal Manometer NRFit; Spinal Manometer LUER PAJUNK GmbH Medizintechnologie, DE | FMJ |
| Aug 28, 2003 | K032432 | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER Busse Hospital Disposables, Inc. | FMJ |
| Apr 7, 1997 | K970287 | LUMBAR PUNCTURE KIT B.Braun Medical, Inc. | FMJ |
| Oct 18, 1996 | K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) Smiths Industries Medical Systems, Inc. | FMJ |
| Jun 20, 1991 | K910089 | MEGA LUMBAR PUNCTURE KIT Megadyne Medical Products, Inc. | FMJ |
| Jun 29, 1988 | K882405 | HYPODERMIC NEEDLE SHEATH HOLDER Ansr Ent., Inc. | FMJ |
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