Panels › General Hospital › Product code LDR · Class 2
Controller, Infusion, Intravascular, Electronic
Regulation 880.5725
0510(k)s in 12 months (60 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in LDR
| Company | 510(k)s | Recalls |
|---|---|---|
| Y | 8 | 0 |
| ConMed Corporation | 0 | 4 |
| Travenol Laboratories, S.A. | 4 | 0 |
| Abbott Laboratories | 3 | 0 |
| DEKA Research & Development | 3 | 0 |
| Ivy Medical, Inc. | 3 | 0 |
| Alexander Mfg. Co. | 2 | 0 |
| Anatros Corp. | 2 | 0 |
| Betaflo, Inc. | 2 | 0 |
| Cosmetic Sciences, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2017 | ConMed Corporation STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2 I.V. Controller, (2) S2-12, STAT 2 Extension Set Gravity Flow Terminated |
LDR | K905498 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller, 12" length, Catalog/REF No. P-S2-12, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is Terminated |
LDR | K905498 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogeni Terminated |
LDR | K905498 |
| Jan 11, 2012 | ConMed Corporation STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path.
For co Terminated |
LDR | K905498 |
| Jun 21, 2011 | Leventon S. A. U. "***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 UNITS***STERILE OE***LATEX-FREE***LEVENTON LEVENTON, S.A.U. C/Newton, 18- Terminated |
LDR | K851058 |
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