Bioseal

Medical device manufacturer in Placentia, CA.

10510(k) clearances
0PMA approvals
5recalls

Device types

510(k) clearances

510(k)DeviceDecision
K893814Surgical Instrument Kit, DisposableLRO · Traditional 08/10/1989SE
K882695Rubber Band, SterileECI · Traditional 10/13/1988SE
K882696Dermicel, Montgomery StrapNAD · Traditional 08/26/1988SE
K882694Fixation Device, Trach TubeCBH · Traditional 08/15/1988SE
K882712Stick SpongeEFQ · Traditional 08/03/1988SE
K882711Gauze Sponge 12PLYEFQ · Traditional 08/03/1988SE
K882710Intestinal SpongesEFQ · Traditional 08/03/1988SE
K882709Tonsil Sponge, X-Ray Detectable, W/StringGDY · Traditional 08/03/1988SE
K882708Gauze Sponge, X-Ray DetectableGDY · Traditional 08/03/1988SE
K882707Gauze Packing, X-Ray DetectableGDY · Traditional 08/03/1988SE

Recalls

RecallProductInitiated
Z-1624-2021 Class IIBioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF:…Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus… 03/23/2021Completed
Z-1623-2021 Class IIBioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF:…Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus… 03/23/2021Completed
Z-1622-2021 Class IIBioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF:…Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus… 03/23/2021Completed
Z-2795-2020 Class IIBioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use…The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in… 08/15/2019Terminated
Z-0085-2018 Class IICustom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument…Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline… 10/18/2017Completed