Bioseal
Placentia, CA, US
BIOSEAL appears in FDA device records in Placentia, CA. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Bioseal between 1988 and 1989. The busiest year on record is 1988, with 9. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 9 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K893814 | SURGICAL INSTRUMENT KIT, DISPOSABLE | LRO | Substantially Equivalent | |
| K882695 | RUBBER BAND, STERILE | ECI | Substantially Equivalent | |
| K882696 | DERMICEL, MONTGOMERY STRAP | NAD | Substantially Equivalent | |
| K882694 | FIXATION DEVICE, TRACH TUBE | CBH | Substantially Equivalent | |
| K882712 | STICK SPONGE | EFQ | Substantially Equivalent | |
| K882711 | GAUZE SPONGE 12PLY | EFQ | Substantially Equivalent | |
| K882710 | INTESTINAL SPONGES | EFQ | Substantially Equivalent | |
| K882709 | TONSIL SPONGE, X-RAY DETECTABLE, W/STRING | GDY | Substantially Equivalent | |
| K882708 | GAUZE SPONGE, X-RAY DETECTABLE | GDY | Substantially Equivalent | |
| K882707 | GAUZE PACKING, X-RAY DETECTABLE | GDY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2027062 | 2027062 | BIOSEAL | 167 WEST ORANGETHORPE AVE., PLACENTIA, CA 92870 US | 2026 | and 119 more, listed in full below |
| 3043620414 | 3043620414 | Bioseal | 801 Industrial Blvd Ste 100, Grapevine, TX 76051 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- ECIBand, Elastic, Orthodontic
- FQMBandage, Elastic
- FNYBasin, Emesis
- GFABlade, Saw, General & Plastic Surgery, Surgical
- BTXBoard, Arm (With Cover), Sterile
- EPEBrush, Cleaning, Tracheal Tube
- GEDBrush, Dermabrasion, Manual
- GECBrush, Scrub, Operating-Room
- FCYBulb, Inflation, For Endoscope
- EJLBur, Dental
- FGYCannula, Injection
- CATCannula, Nasal, Oxygen
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- GBACatheter, Balloon Type
- GBXCatheter, Irrigation
- DQYCatheter, Percutaneous
- BZAConnector, Airway (Extension)
- FMHContainer, Specimen, Sterile
- EFNCotton, Roll
- FXPCover, Shoe, Operating-Room
- EIEDam, Rubber
- FMADepressor, Tongue, Non-Surgical
- CBHDevice, Fixation, Tracheal Tube
- FODDevice, Occlusion, Umbilical
- FRLFiber, Medical, Absorbent
- EFQGauze/Sponge, Internal
- GDYGauze/Sponge, Internal, X-Ray Detectable
- GDFGuide, Needle, Surgical
- FKFGun, Tie, Dialysis
- DZEImplant, Endosseous, Root-Form
- FHNLigator, Hemorrhoidal
- FZZMarker, Skin
- DYNMouthpiece, Saliva Ejector
- DWONeedle, Biopsy, Cardiovascular
- BRWProtector, Dental
- FMPProtector, Skin Pressure
- FMQRestraint, Protective
- EIGRetractor, All Types
- FDGRetractor, Fiberoptic
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- FXGSpecula Accessories
- EPYSpeculum, Ent
- HDFSpeculum, Vaginal, Metal
- HIBSpeculum, Vaginal, Nonmetal
- HICSpeculum, Vaginal, Nonmetal, Fiberoptic
- FYHSplint, Extremity, Noninflatable, External, Sterile
- EPPSplint, Nasal
- HOZSponge, Ophthalmic
- CCXSupport, Patient Position
- FMFSyringe, Piston
- FHFSystem, Evacuator, Fluid
- FTYTape, Measuring, Rulers And Calipers
- EFWToothbrush, Manual
- GAXTourniquet, Nonpneumatic
- GAZTubing, Noninvasive
- FMTWarmer, Infant Radiant
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1624-2021 | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096 | Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. | Class II | Completed | |
| Z-1623-2021 | Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177 | Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. | Class II | Completed | |
| Z-1622-2021 | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157 | Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. | Class II | Completed | |
| Z-2795-2020 | 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 connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask. | The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient. | Class II | Terminated | |
| Z-0085-2018 | 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 Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50 | Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date. | Class II | Completed |
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Data as of , FDA export datePage updated Source: openFDA, public domain