ClearanceBrief
Company

Baxter Bioscience

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
NBESealant, Polymerizing3
FMFSyringe, Piston1
LMFAgent, Absorbable Hemostatic, Collagen Based1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 2, 2010Baxter Bioscience
Coseal Surgical Sealant 8mL, Product Codes: 934072 & 934075. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
Terminated
NBENone listed
Jul 2, 2010Baxter Bioscience
Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
Terminated
NBENone listed
Jul 2, 2010Baxter Bioscience
Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
Terminated
NBENone listed
Sep 20, 2008Baxter Bioscience
FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological) as an adjunct to hemostasis when control
Terminated
LMFNone listed
Nov 24, 2007Baxter Bioscience
Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FMFK020666
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