FDA Registration
Active
🇺🇸 United States
BIOSEAL
Reg #: 2027062
·
FEI: 2027062
·
Expires 2026
Products
129
Proprietary Names
159
Establishment Types
4
Classifications
129
Registration Details
- Registration Name
- BIOSEAL
- Registration Number
- 2027062
- FEI Number
- 2027062
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 167 WEST ORANGETHORPE AVE.
- City
- PLACENTIA
- State
- CA
- ZIP
- 92870
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180937
Owner / Operator
- Firm Name
- BIOSEAL
- Operator Number
- 2027062
- Address
- 167 WEST ORANGETHORPE AVE., --
- City
- Placentia
- State
- CA
- Postal Code
- 92870
- Country
- US
- Correspondent
- WILLIAM L RUNION
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2018-04-16 |
| Fork | HXE | Class 1 | Orthopedic | No | 2026-01-13 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 1992-11-12 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-12-03 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2020-08-17 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 1992-11-12 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 1992-11-12 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2012-02-15 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2012-11-07 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2025-03-31 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2025-03-31 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 1992-11-12 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2026-01-07 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-11-27 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2025-03-31 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2018-04-16 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2016-08-12 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2022-05-10 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-12-04 |
| Speculum, Vaginal, Nonmetal, Fiberoptic | HIC | Class 2 | Obstetrics/Gynecology | No | 2019-01-30 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2015-07-02 |
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 2020-12-22 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2014-05-13 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2016-08-15 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2010-11-17 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2021-06-15 |
| Specula Accessories | FXG | Class 1 | General, Plastic Surgery | No | 2018-11-26 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2018-08-03 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2025-12-17 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2023-07-06 |
| Stabilizer, Heart | MWS | Class 1 | Cardiovascular | No | 2012-10-25 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2018-12-03 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2010-11-17 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2018-04-16 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2018-05-08 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2018-05-08 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-05-08 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2019-01-24 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2019-01-28 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | Class 1 | General Hospital | No | 2010-06-09 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2021-06-08 |
| Board, Arm (With Cover), Sterile | BTX | Class 1 | General, Plastic Surgery | No | 2011-03-02 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2016-08-12 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2012-12-05 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2021-07-01 |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | Class 1 | General, Plastic Surgery | No | 2023-05-17 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2014-04-02 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2010-11-17 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2025-03-31 |
| Bone Indentation Device | QGQ | Class 2 | Orthopedic | No | 2021-10-29 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2019-06-28 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2010-07-26 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2019-08-16 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2010-06-09 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2011-08-18 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2016-08-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-10-29 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2018-04-16 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 1992-11-12 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 1992-11-12 |
| Floss, Dental | JES | Class 1 | Dental | No | 2022-09-14 |
| Ear Wick | KCN | Class 1 | Ear, Nose, Throat | No | 2025-01-08 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2016-08-15 |
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2010-07-08 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 1992-11-12 |
| Brush, Cleaning, Tracheal Tube | EPE | Class 1 | Anesthesiology | No | 2010-06-14 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2018-04-16 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2016-08-12 |
| Gun, Tie, Dialysis | FKF | Class 1 | Gastroenterology, Urology | No | 2018-04-16 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2021-02-26 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2012-06-26 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2019-10-21 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2018-04-16 |
| Accessories, Traction | ILZ | Class 1 | Physical Medicine | No | 2013-03-21 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2010-09-14 |
| Tube, Tissue Culture | KJG | Class 1 | Pathology | No | 2010-07-08 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2025-03-31 |
| Brush, Dermabrasion, Manual | GED | Class 1 | General, Plastic Surgery | No | 2018-07-23 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-02-13 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2024-08-08 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2015-02-25 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-03-31 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2018-12-03 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2026-01-28 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2026-01-28 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2023-07-13 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2010-06-14 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 1988-08-15 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 1992-11-12 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2018-12-03 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2018-12-03 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-07-23 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2010-06-14 |
| Bulb, Inflation, For Endoscope | FCY | Class 1 | Gastroenterology, Urology | No | 2010-03-01 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2023-09-26 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2019-01-30 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2016-05-24 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 1992-11-12 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2023-07-07 |
| Battery, Replacement, Rechargeable | MOQ | Class 1 | General, Plastic Surgery | No | 2016-03-29 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2016-08-15 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2018-08-03 |
| Film, Radiographic | IWZ | Class 1 | Radiology | No | 2018-09-26 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2012-07-03 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2018-05-08 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2016-08-12 |
| System, Evacuator, Fluid | FHF | Class 2 | Gastroenterology, Urology | No | 2023-09-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-11-26 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2010-11-17 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2018-04-16 |
| Cuff, Nerve | JXI | Class 2 | Neurology | No | 2024-03-20 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2007-11-09 |
| Catheter, Balloon Type | GBA | Class 1 | General, Plastic Surgery | No | 2021-07-06 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2012-11-07 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2019-10-14 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2024-08-09 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2018-07-27 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2018-07-27 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2016-08-15 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2021-02-26 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2001-06-13 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2023-05-17 |
| Chamber, Oxygen, Topical, Extremity | KPJ | Class 2 | General, Plastic Surgery | No | 2023-07-06 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-08-25 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2010-07-08 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2016-08-12 |
| Splint, Nasal | EPP | Class 1 | Ear, Nose, Throat | No | 2010-06-09 |
Proprietary Names
Mouthguard
Sterile Tonsil Sponges
Cohere
Kinos Axiom Total Ankle System
Non-Sterile Cotton Tipped Applicators
Non-Sterile Manual Surgical Instruments
Sterile Manual Surgical Instruments
American Medical Sterile Surgical Instrument
Filters, paper
Sterile Medicine Cup
Instrument, Biopsy BMAN Neuro
Neurosurgical Nerve Locator BMAN Neuro
Sterile Esmark
Non-Sterile Elastic Bandage
Sterile Elastic Bandage
DynaNail
System Facet Screw Spinal Device ION Transfacet
Toothpick
Razor Blade Single Edge
Feather Blade Double Edge
Razor Prep Blade Single Edge
Autopsy Blade
Sightline
Vaginal Speculum Fiber Optic
Sterile Wooden Tongue Depressor
Bioseal
Zip-lock
ReSeal
Organ
Vaginal Speculum
Sterile Tape
Sterile Adhesive Bandage
Ocular Exam Kit
Crash Cart
ZIP MIS INTERSPINOUS FUSION SYSTEM
Interbody
Accutemp Probe
Dr. Karlson's Heart Bag
Advantage-C PEEK Cervical Interbody Fusion Device
LifeBubble
Sterile Aluminum Washer
Sponge, opthalmic
TrackX
suction tubing
sheet
blanket
Breast Pad, Sterile
Wedge
Sterile Armboard
System Facet Screw Spinal Device ION 3D- Screws with Windows
Disposable Guardian Canister
Disposable Suction Canister
Sterile Button
Nail Splint
Smart Gauze, Sterile Gauze, Gauze Roll
Sterile Skin Marker
Sacroiliac Joint Fixation Tilink-P Slotted Screw
OsteoProbe
Hemorrhoidal Ligator
Sacroiliac Joint Fixation- TiLink-P 3D Anchor and Disposable
Sterile Culture Tube
Simple Solutions Medical
Osteoflo
Toothbrush, Sterile
Sterile Stethoscope
Body Restraint
Suture Passer/Retriever
Safeview Retrograde Knife
Wire Brushes for use with FlareHawk Interbody Fusion System
Cage
Bite Block
Sterile Impervious Stockinette
Sterile Bias Stockinette
Sterile Tubular Stockinette
Sterile Circumcision Trays
Sterile General Instrument Set
Sterile Dressing Change Kit
Sterile Suture Removal Set
Sterile Laceration Trays
Sterile Pelvic Exam Kits
Sterile Suturing Tray
Spectrum Syringe/Lateral Flow Vented Needle Pack
Dental Floss
Ear Speculum
Sterile Petri Dish
Cotton Balls Sterile
Rayon Balls Sterile
Cast Padding Sterile
Trach Brush
Support, patient position
Sheet Silastic
Zip ties, zip tie gun
Vertera Spine Cohere Cervical Interbody Fusion Device
JosNoe
Sterile Labels
Laguna Coast
Saliva Ejector
Cleaning Brush Endo
Sterile S-hook
Non-sterile S- Hook
non-sterile traction Rope
Sterile Traction Rope
Sterile Felt, Foam & padding materials
System Facet Screw Spinal Device ION 3D-Disposable and Rasp
RASP -ION 3D-Disposable and Rasp
Sand Paper
ALARA
Duraholder IPS
CaraClips
Dental Bur
BINASAL AIRWAY
RASP - ION 3D Cannulated with Windows
System Facet Screw Spinal Device ION 3D Cannulated with Windows
GraftGun Universal Graft Delivery System (GDS)
Accudepth
Fiber Scribe
Tape, Measuring, Rulers & Calipers
sterile bands
Sterile Trach Tape
Coalesce
Stockinette Tubular
Stockinette Impervious
Drape
Tourniquet
Intervertebral Fusion Device With Bone Graft, Cervical
Bulb and Bladder
Kerrison System Kit
Vaginal Speculum Metal
Glove Liner
Bioseal Shields
Sterile Basin
Graftgun Universal Graft Delivery System
Drain, penrose and others
Injection Kit
Battery, replacement
Berman Airway
Orthopedic Accessory
X-Ray Film
Umbilical Tape
WoundPro
Shoe Cover
Clearwand
Drill Guide
Sterile Eye Sheild
Sacroiliac Joint Fixation TiLink-P
Cannula Oxygen
Nerve Tape
Non-Sterile Suction Tubing
Sterile Suction Tubing
Sterile Scrub Brush
Implanova
Lube Jelly Surgilube
ABSORBENT TIPPED
Bioseal Cheek Retractor
Numobag
DEXA SOLO-L Standalone Anterior Fusion System
Sterile Microscope Slides
Dental Roll
X-Ray Film, Sterile
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)