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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)

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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 259-025050 UNITSSTERILE OELATEX-FREE*LEVENTON LEVENTON, S.A.U. C/Newton, 18- Terminated	LDR	K851058

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