Company ยท US
Bioseal
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1989. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 1989 | K893814 | SURGICAL INSTRUMENT KIT, DISPOSABLE Bioseal | LRO |
| Oct 13, 1988 | K882695 | RUBBER BAND, STERILE Bioseal | ECI |
| Aug 26, 1988 | K882696 | DERMICEL, MONTGOMERY STRAP Bioseal | NAD |
| Aug 15, 1988 | K882694 | FIXATION DEVICE, TRACH TUBE Bioseal | CBH |
| Aug 3, 1988 | K882712 | STICK SPONGE Bioseal | EFQ |
| Aug 3, 1988 | K882711 | GAUZE SPONGE 12PLY Bioseal | EFQ |
| Aug 3, 1988 | K882710 | INTESTINAL SPONGES Bioseal | EFQ |
| Aug 3, 1988 | K882709 | TONSIL SPONGE, X-RAY DETECTABLE, W/STRING Bioseal | GDY |
| Aug 3, 1988 | K882708 | GAUZE SPONGE, X-RAY DETECTABLE Bioseal | GDY |
| Aug 3, 1988 | K882707 | GAUZE PACKING, X-RAY DETECTABLE Bioseal | GDY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2021 | Bioseal Corporation Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096 Completed |
KDD | None listed |
| Mar 23, 2021 | Bioseal Corporation Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177 Completed |
KDD | None listed |
| Mar 23, 2021 | Bioseal Corporation Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157 Completed |
KDD | None listed |
| Aug 15, 2019 | Bioseal Corporation Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connec Terminated |
BZA | None listed |
| Oct 18, 2017 | Bioseal Corporation Custom surgical kits labeled as follows:
(a) Suture Removal Set, 910-0002
(b) Instrument Set, INST03/20
(c) Suture Removal Set, SUT309/100
(d) Incision & Drainage Tray, INC03/20
(e) Suture Remova Completed |
KDD | None listed |