Panels › Gastroenterology, Urology › Product code FIE · Class 2
Needle, Fistula
Regulation 876.5540
1510(k)s in 12 months (80 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in FIE
| Company | 510(k)s | Recalls |
|---|---|---|
| Jms Co., Ltd. | 12 | 0 |
| JMS North America Corporation | 10 | 0 |
| Medisystems Corp. | 6 | 1 |
| Nipro Medical Corp. | 6 | 0 |
| Sorensen Research | 6 | 0 |
| Hospal Medical Corp. | 4 | 0 |
| HK Surgical Inc | 0 | 3 |
| Bain Medical Equipment (Guangzhou) Co., Ltd. | 2 | 0 |
| Medisystems a NX Stage Company | 0 | 2 |
| Terumo America, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 1989 | K891062 | TERUMO AV FISTULA NEEDLE SET Terumo Medical Corp. | FIE |
| Mar 16, 1988 | K880726 | JMS APHERESIS NEEDLE Jms Co., Ltd., JP | FIE |
| Jun 27, 1986 | K862002 | MEDISYSTEMS PHERESIS NEEDLE Medisystems Corp. | FIE |
| Apr 8, 1986 | K854773 | SUPERCATH A.V. FISTULA Togo Medikit Co., Ltd., JP | FIE |
| Mar 18, 1986 | K860789 | JMD AV FISTULA NEEDLE (MODIFICATION) Jms Co., Ltd., JP | FIE |
| Feb 26, 1986 | K860449 | MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE Top Corp. | FIE |
| Feb 5, 1986 | K860241 | JMS AV FISTULA NEEDLE Jms Co., Ltd., JP | FIE |
| Jan 8, 1986 | K854951 | PLUME Y SET Hospal Medical Corp. | FIE |
| Apr 29, 1985 | K851453 | HOSPAL FISTULA NEEDLE Hospal Medical Corp. | FIE |
| Jan 8, 1985 | K844343 | TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE Top Surgical Manufacturers Co. | FIE |
| Oct 14, 1983 | K832136 | DUAL FLOW NEEDLE Travenol Laboratories, S.A. | FIE |
| Sep 24, 1981 | K812621 | DELTA-A.V. FISTULA CANNULATION SET Amisco Trading Corp. | FIE |
| Sep 8, 1981 | K811838 | MEDISYSTEMS FISTULA NEEDLE Medisystems Corp. | FIE |
| Dec 22, 1980 | K802956 | GAMBRO A-V FISTULA NEEDLE SET Gambro, Inc. | FIE |
| Sep 26, 1980 | K801966 | HEMO-CATH II KIDNEY DIALYSIS CATHETER Medical Components, Inc. | FIE |
| Aug 13, 1980 | K801618 | ARGYLE A-V MEDI-WING HEMODIALYSIS SET Sherwood Medical Co. | FIE |
| Aug 4, 1980 | K801632 | THE BELLCO FISTULA NEEDLES Bellco Artifidial Organ Spec., Inc. | FIE |
| Oct 26, 1979 | K791490 | UNIPUNCTURE CATHETER Hospal Medical Corp. | FIE |
| Oct 26, 1979 | K791489 | VITAL CATHETER Hospal Medical Corp. | FIE |
| Mar 21, 1979 | K782021 | A.V. FISTULA NEEDLE SET Cordis Corp. | FIE |
| Mar 17, 1978 | K772362 | AVF SET FOR SINGLE NEEDLE HEMODIALYSIS Terumo America, Inc. | FIE |
| Aug 16, 1977 | K771495 | A.V. FISTULA NEEDLE SET (#361) Sorensen Research | FIE |
| Aug 16, 1977 | K771494 | A.V. FISTULA NEEDLE SET (354) Sorensen Research | FIE |
| Aug 16, 1977 | K771493 | A.V. FISTULA NEEDLE SET (#341) Sorensen Research | FIE |
| Aug 16, 1977 | K771492 | A.V. FISTULA NEEDLE SET (#351) Sorensen Research | FIE |
| Aug 16, 1977 | K771491 | A.V. FISTULA NEEDLE SET (#364) Sorensen Research | FIE |
| Aug 16, 1977 | K771490 | A.V. FISTULA NEEDLE SET (#344) Sorensen Research | FIE |
| Jul 15, 1977 | K771206 | AV FISTULA NEEDLE SET Terumo America, Inc. | FIE |
| Jun 24, 1977 | K770864 | HEMODIALYSIS FISTULA SET Venospital, Inc. | FIE |
| Jun 14, 1977 | K770699 | NEEDLE SET, A-V FISTULA Medical Disposables Intl., Inc. | FIE |
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