Panels › Gastroenterology, Urology › Product code KDL · Class 2
Set, Perfusion, Kidney, Disposable
Regulation 876.5880
0510(k)s in 12 months (19 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in KDL
| Company | 510(k)s | Recalls |
|---|---|---|
| Dr. Franz Kohler Chemie GmbH | 3 | 0 |
| Institut Georges Lopez | 2 | 0 |
| S.A.L.F. Spa | 2 | 0 |
| Organ Recovery Systems, Inc. | 1 | 1 |
| Waters Medical Systems, LLC | 2 | 0 |
| Baxter Healthcare Corp. | 0 | 1 |
| Bivona Medical Technologies | 1 | 0 |
| Bridge TO Life, Ltd. | 1 | 0 |
| Cobe Renal Care, Inc. | 1 | 0 |
| Dow Corning Corp. Healthcare Industries Materials | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 2025 | K241239 | OrganProtex HTK Solution Bridge TO Life, Ltd. | KDL |
| Jun 14, 2022 | K221387 | BEL-GEN Cold Storage Solution Institut Georges Lopez, FR | KDL |
| Jun 14, 2022 | K221386 | PERF-GEN Pulsatile Perfusion Solution Institut Georges Lopez, FR | KDL |
| Dec 20, 2021 | K211842 | Servator M SALF Solution S.A.L.F. Spa, IT | KDL |
| Apr 24, 2020 | K192408 | Custodiol HTK Solution Dr. Franz Kohler Chemie GmbH, DE | KDL |
| Oct 20, 2017 | K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags S.A.L.F. Spa, IT | KDL |
| Aug 16, 2013 | K121736 | PERF-GEN PULSATILE PERFUSION SOLUTION Waters Medical Systems, LLC | KDL |
| Jun 14, 2013 | K121618 | BEL-GEN COLD STORAGE SOLUTION Waters Medical Systems, LLC | KDL |
| Mar 11, 2010 | K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L Organ Recovery Systems, Inc. | KDL |
| Feb 28, 2005 | K043461 | CUSTODIOL Dr. Franz Kohler Chemie GmbH | KDL |
| Jan 6, 2003 | K020924 | CUSTODIOL HTK SOLUTION Dr. Franz Kohler Chemie GmbH | KDL |
| Sep 25, 1997 | K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET Cobe Renal Care, Inc. | KDL |
| Apr 22, 1996 | K944866 | VIASPAN (BELZER UW - CSS) The Dupont Merck Pharmaceutical Co. | KDL |
| Mar 20, 1990 | K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) The DU Pont Co. | KDL |
| Nov 28, 1989 | K891239 | MOP CATHETER Bivona Medical Technologies | KDL |
| Apr 20, 1989 | K883782 | BELZER UW-CSS Du Pont Critical Care | KDL |
| Jan 26, 1989 | K884609 | EURO-COLLINS SOLUTION SETS Fresenius USA, Inc., DE | KDL |
| Apr 27, 1978 | K780470 | H.P. MEDICAL GRADE SILICONE TUBING Dow Corning Corp. Healthcare Industries Materials | KDL |
| Nov 19, 1976 | K760922 | PERFUSION TUBING SET Shiley, Inc. | KDL |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.