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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2024 | Dr Franz Koehler Chemie Gmbh Custodiol HTK Solution, 500ml bottle. 10 per carton. Open, Classified |
KDL | K192408 |
| Dec 14, 2016 | Organ Recovery Systems, Inc. SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143 Terminated |
KDL | K091656 |
| Nov 8, 2016 | Baxter Healthcare Corp. GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634
Product Usage:
The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal fail Terminated |
KDL | K060195 |
| Apr 18, 2012 | Teva Pharmaceuticals USA, Inc. ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags).
Disposable kidney perfusion set. Terminated |
KDL | K944866 |
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