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
Protector, Dental BRW
Fork HXE
Gauze/Sponge, Internal, X-Ray Detectable GDY
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
Applicator, Absorbent Tipped, Non-Sterile KXF
Instrument, Surgical, Disposable KDC
Filters, Cell Collection, Tissue Processing KET
Container, Liquid Medication, Graduated KYW
Neurosurgical Nerve Locator PDQ
Instrument, Biopsy KNW
Bandage, Elastic FQM
Filler, Bone Void, Calcium Compound MQV
Rod, Fixation, Intramedullary And Accessories HSB
System, Facet Screw Spinal Device MRW
Pick, Massaging JET
Razor, Surgical LWK
Blade, Saw, General & Plastic Surgery, Surgical GFA
Template HWT
Speculum, Vaginal, Nonmetal, Fiberoptic HIC
Depressor, Tongue, Non-Surgical FMA
Needle, Biopsy, Cardiovascular DWO
Bag, Intestine KGY
Speculum, Vaginal, Nonmetal HIB
Tape And Bandage, Adhesive KGX
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Specula Accessories FXG
Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
Spinous Process Plate PEK
Warmer, Infant Radiant FMT
Stabilizer, Heart MWS
Device, Intravascular Catheter Securement KMK
System, X-Ray, Film Marking, Radiographic JAC
Sponge, Ophthalmic HOZ
System, X-Ray, Fluoroscopic, Image-Intensified JAA
Interventional Fluoroscopic X-Ray System OWB
System, Image Processing, Radiological LLZ
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Bedding, Disposable, Medical KME
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) NTX
Bone Wedge PLF
Board, Arm (With Cover), Sterile BTX
Bottle, Collection, Vacuum KDQ
Retention Device, Suture KGS
Catheter And Tip, Suction JOL
Splint, Extremity, Noninflatable, External, Sterile FYH
Gauze / Sponge,Nonresorbable For External Use NAB
Marker, Skin FZZ
Sacroiliac Joint Fixation OUR
Bone Indentation Device QGQ
Ligator, Hemorrhoidal FHN
Container, Specimen, Sterile FMH
Connector, Airway (Extension) BZA
Toothbrush, Manual EFW
Stethoscope, Manual LDE
Restraint, Protective FMQ
Orthopedic Manual Surgical Instrument LXH
Endoscopic Bite Block MNK
Cover, Limb IPM
Kit, Surgical Instrument, Disposable KDD
Floss, Dental JES
Ear Wick KCN
Speculum, Ent EPY
Dish, Tissue Culture KIZ
Fiber, Medical, Absorbent FRL
Brush, Cleaning, Tracheal Tube EPE
Support, Patient Position CCX
Dam, Rubber EIE
Gun, Tie, Dialysis FKF
Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
Label Or Tag, Sterile LYV
Mouthpiece, Saliva Ejector DYN
Accessories, Cleaning Brushes, For Endoscope MNL
Accessories, Traction ILZ
Protector, Skin Pressure FMP
Tube, Tissue Culture KJG
Rasp HTR
Brush, Dermabrasion, Manual GED
Guide, Needle, Surgical GDF
Instrument, Manual, Surgical, General Use MDM
Bur, Dental EJL
Airway, Nasopharyngeal BTQ
Syringe, Piston FMF
Passer, Wire, Orthopedic HXI
Catheter, Percutaneous DQY
Catheter, Percutaneous, Neurovasculature QJP
Retractor, Fiberoptic FDG
Tape, Measuring, Rulers And Calipers FTY
Band, Elastic, Orthodontic ECI
Device, Fixation, Tracheal Tube CBH
Intervertebral Fusion Device With Bone Graft, Thoracic PHM
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Drape, Surgical, Exempt PUI
Tourniquet, Nonpneumatic GAX
Bulb, Inflation, For Endoscope FCY
Rongeur HTX
Speculum, Vaginal, Metal HDF
Accessory, Surgical Apparel LYU
Basin, Emesis FNY
Catheter, Irrigation GBX
Cannula, Injection FGY
Battery, Replacement, Rechargeable MOQ
Airway, Oropharyngeal, Anesthesiology CAE
Apparatus, Traction, Non-Powered HST
Film, Radiographic IWZ
Device, Occlusion, Umbilical FOD
Negative Pressure Wound Therapy Powered Suction Pump OMP
Cover, Shoe, Operating-Room FXP
System, Evacuator, Fluid FHF
Bit, Drill HTW
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Cannula, Nasal, Oxygen CAT
Cuff, Nerve JXI
Tubing, Noninvasive GAZ
Catheter, Balloon Type GBA
Brush, Scrub, Operating-Room GEC
Tray, Surgical LRP
Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE
Lubricant, Patient KMJ
Laparoscopic Accessories, Gynecologic NWV
Applicator, Absorbent Tipped, Sterile KXG
Retractor, All Types EIG
Chamber, Oxygen, Topical, Extremity KPJ
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Slides, Microscope KEW
Cotton, Roll EFN
Splint, Nasal EPP

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)