Data / Medical devices / United States / Bioseal
Bioseal: FDA-registered device maker in Placentia, CA, United States, 1 510(k) clearance
Bioseal is registered with the FDA (registration 2027062) in Placentia, CA, United States. It lists 130 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 10, 2018. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2027062
- Address
- 167 West Orangethorpe Ave., Placentia, CA, United States, 92870
- Owner or operator
- BIOSEAL (2027062)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler
- First device listed
- August 15, 1988
- Registered through
- 2027
- Brand names listed
- ABSORBENT TIPPED, ALARA, Accudepth, Accutemp Probe, Advantage-C PEEK Cervical Interbody Fusion Device, American Medical Sterile Surgical Instrument, Autopsy Blade, BINASAL AIRWAY and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer | accessdata.fda.gov |
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Traction | ILZ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Airway, Nasopharyngeal | BTQ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | 1 | Contract manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Traction, Non-Powered | HST | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bag, Intestine | KGY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Battery, Replacement, Rechargeable | MOQ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Contract manufacturer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Board, Arm (With Cover), Sterile | BTX | 1 | Contract sterilizer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bone Indentation Device | QGQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Bone Wedge | PLF | 2 | Contract manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Brush, Cleaning, Tracheal Tube | EPE | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Brush, Dermabrasion, Manual | GED | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bulb, Inflation, For Endoscope | FCY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Injection | FGY | 1 | Contract manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Balloon Type | GBA | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Contract manufacturer | accessdata.fda.gov |
| Chamber, Oxygen, Topical, Extremity | KPJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cover, Limb | IPM | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cuff, Nerve | JXI | 2 | Contract manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Contract manufacturer | accessdata.fda.gov |
| Device, Occlusion, Umbilical | FOD | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dish, Tissue Culture | KIZ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Ear Wick | KCN | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Contract manufacturer | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Filters, Cell Collection, Tissue Processing | KET | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fork | HXE | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Contract manufacturer | accessdata.fda.gov |
| Gun, Tie, Dialysis | FKF | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Contract manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Label Or Tag, Sterile | LYV | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Contract manufacturer | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Biopsy, Cardiovascular | DWO | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Contract manufacturer | accessdata.fda.gov |
| Neurosurgical Nerve Locator | PDQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Contract manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | 2 | Contract manufacturer | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rasp | HTR | 1 | Contract manufacturer | accessdata.fda.gov |
| Razor, Surgical | LWK | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retention Device, Suture | KGS | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Fiberoptic | FDG | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Contract manufacturer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Contract manufacturer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Contract manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Specula Accessories | FXG | 1 | Contract manufacturer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal, Fiberoptic | HIC | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Contract manufacturer | accessdata.fda.gov |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Splint, Nasal | EPP | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stabilizer, Heart | MWS | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Evacuator, Fluid | FHF | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Facet Screw Spinal Device | MRW | U | Contract manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Contract manufacturer | accessdata.fda.gov |
| System, X-Ray, Film Marking, Radiographic | JAC | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Contract manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Template | HWT | 1 | Contract manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tube, Tissue Culture | KJG | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Contract manufacturer | accessdata.fda.gov |
| Warmer, Infant Radiant | FMT | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 10, 2018 | K180937 | Graftgun Universal Graft Delivery System | FMF | Substantially Equivalent | SurGenTec, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 23, 2021 | 87636 | Class II | Completed | 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. | accessdata.fda.gov |
| August 15, 2019 | 85288 | Class II | Terminated | 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 con | 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. | accessdata.fda.gov |
| October 18, 2017 | 78375 | Class II | Completed | Custom surgical kits labeled as follows: (a) Suture Removal Set, (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 Purpo | Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date. | accessdata.fda.gov |
Compare with other makers
- All makers of Marker, Skin
- All makers of Neurosurgical Nerve Locator
- All makers of Instrument, Biopsy
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Bit, Drill
Updated May 10, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.