BIOSEAL

FDA Device Registration & Listing · PLACENTIA, CA, US · Registration 2027062

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2027062
FEI Number
2027062
Entity Name
BIOSEAL
City/State/Country
PLACENTIA, CA, US
Establishment Address
167 WEST ORANGETHORPE AVE., PLACENTIA, CA 92870, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
BIOSEAL (Owner Number: 2027062)
Owner / Operator Contact Address
167 WEST ORANGETHORPE AVE., --, Placentia, CA 92870, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Bioseal 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 Bioseal 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 Bioseal 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 Sterile Culture Tube 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 Interbody 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BRW Protector, Dental Anesthesiology Class 1 868.5820 2018-04-16
HXE Fork Orthopedic Class 1 888.4540 2026-01-13
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 1992-11-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-12-03
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2020-08-17
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 1992-11-12
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 1992-11-12
KET Filters, Cell Collection, Tissue Processing Pathology Class 1 864.3010 2012-02-15
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2012-11-07
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-03-31
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2025-03-31
FQM Bandage, Elastic General Hospital Class 1 880.5075 1992-11-12
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-01-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-11-27
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2025-03-31
JET Pick, Massaging Dental Class 1 872.6650 2018-04-16
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2016-08-12
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2022-05-10
HWT Template Orthopedic Class 1 888.4800 2018-12-04
HIC Speculum, Vaginal, Nonmetal, Fiberoptic Obstetrics/Gynecology Class 2 884.4530 2019-01-30
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2015-07-02
DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery Class 1 878.4800 2020-12-22
KGY Bag, Intestine General, Plastic Surgery Class 1 878.4100 2014-05-13
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2016-08-15
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2010-11-17
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2021-06-15
FXG Specula Accessories General, Plastic Surgery Class 1 878.1800 2018-11-26
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2018-08-03
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2025-12-17
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2022-02-22
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2023-07-06
MWS Stabilizer, Heart Cardiovascular Class 1 870.4500 2012-10-25
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-07-11
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2018-12-03
JAC System, X-Ray, Film Marking, Radiographic Radiology Class 1 892.1640 2010-11-17
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2018-04-16
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2018-05-08
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2018-05-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-05-08
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2019-01-24
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2019-01-28
NTX Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) General Hospital Class 1 880.5630 2010-06-09
PLF Bone Wedge Orthopedic Class 2 888.3030 2021-06-08
BTX Board, Arm (With Cover), Sterile General, Plastic Surgery Class 1 878.3910 2011-03-02
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2025-03-31
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2016-08-12
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2012-12-05
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2021-07-01
FYH Splint, Extremity, Noninflatable, External, Sterile General, Plastic Surgery Class 1 878.3910 2023-05-17
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2014-04-02
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2010-11-17
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2025-03-31
QGQ Bone Indentation Device Orthopedic Class 2 888.1600 2021-10-29
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2019-06-28
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2025-03-31
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2010-07-26
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2019-08-16
HXE Fork Orthopedic Class 1 888.4540 2026-01-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-09-17
EFW Toothbrush, Manual Dental Class 1 872.6855 2010-06-09
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2011-08-18
FMQ Restraint, Protective General Hospital Class 1 880.6760 2016-08-25
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2020-10-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-06-08
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2018-04-16
IPM Cover, Limb Physical Medicine Class 1 890.3025 1992-11-12
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 1992-11-12
JES Floss, Dental Dental Class 1 872.6390 2022-09-14
KCN Ear Wick Ear, Nose, Throat Class 1 874.5220 2025-01-08
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2016-08-15
KIZ Dish, Tissue Culture Hematology Class 1 864.2240 2010-07-08
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 1992-11-12
EPE Brush, Cleaning, Tracheal Tube Anesthesiology Class 1 868.5795 2010-06-14
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2018-04-16
EIE Dam, Rubber Dental Class 1 872.6300 2016-08-12
FKF Gun, Tie, Dialysis Gastroenterology, Urology Class 1 876.5820 2018-04-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-05-08
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-01-07
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2021-02-26
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2012-06-26
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2019-10-21
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2018-04-16
ILZ Accessories, Traction Physical Medicine Class 1 890.5925 2013-03-21
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2010-09-14
KJG Tube, Tissue Culture Pathology Class 1 864.3010 2010-07-08
HTR Rasp General, Plastic Surgery Class 1 878.4800 2025-03-31
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2025-03-31
GED Brush, Dermabrasion, Manual General, Plastic Surgery Class 1 878.4800 2018-07-23
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2018-12-03
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2015-02-13
EJL Bur, Dental Dental Class 1 872.3240 2024-08-08
BTQ Airway, Nasopharyngeal Anesthesiology Class 1 868.5100 2015-02-25
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-02-22
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2025-03-31
HTR Rasp General, Plastic Surgery Class 1 878.4800 2025-03-31
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-03-31
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2018-12-03
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-01-28
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2026-01-28
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 2023-07-13
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2010-06-14
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 1988-08-15
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 1992-11-12
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2018-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-03
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2018-07-23
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2010-06-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-12-17
FCY Bulb, Inflation, For Endoscope Gastroenterology, Urology Class 1 876.1500 2010-03-01
HTX Rongeur Orthopedic Class 1 888.4540 2023-09-26
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2019-01-30
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2016-05-24
FNY Basin, Emesis General Hospital Class 1 880.6730 1992-11-12

Official Correspondent

WILLIAM RUNION

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOSEAL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3043620414 Bioseal Grapevine, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K790050 Stanford Professional Products SPONGES, STANFORD STERILE LAP 1979-01-17
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25
K831798 I M, Inc. DISPOSABLE SCALPELS 1983-07-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2022 Exactech, Inc. 2
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0027-2024 Bard Peripheral Vascular Inc 2
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013 Remington Medical Inc. 2
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014 Atossa Genetics, Inc. 2
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018 Bard Peripheral Vascular Inc 2
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.

Similar Registrations

Registration Number Establishment Name Location
3045076539 SHENZHEN XINJIANLI TECHNOLOGY CO., LTD. Dongguan Guangdong, CN
3001321782 JEFFERSON RUBBER WORKS Worcester, MA, US
3002858762 SPIGGLE & THEIS MEDIZINTECHNIK GMBH OVERATH North Rhine-Westphalia, DE
3014925994 INNOVGAS PTY LTD Docklands Victoria, AU
3043648115 DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD. Shijiazhuang Hebei, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027062. Last updated year: 2026. Please use registration number 2027062 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.