BIOSEAL

Contract manufacturer and sterilizer · Placentia, CA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration: 2027062 (openFDA record; or search FDA's registration database)
FEI number: 2027062
Registered for: FDA registration year 2026
Establishment types: Manufacturer; Contract manufacturer; Repackager or relabeler; Contract sterilizer
Owner or operator: BIOSEAL (FDA owner/operator no. 2027062)
Registered address: 167 WEST ORANGETHORPE AVE., Placentia, CA 92870
Contract listings: 132 device listings, 127 product codes, first listed Aug 15, 1988
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
BRW	Protector, Dental	Class I	Anesthesiology	Contract manufacturing	Apr 16, 2018
BTQ	Airway, Nasopharyngeal	Class I	Anesthesiology	Contract manufacturing	Feb 25, 2015
BTX	Board, Arm (With Cover), Sterile	Class I	General and plastic surgery	Contract sterilization	Mar 2, 2011
BZA	Connector, Airway (Extension)	Class I	Anesthesiology	Contract manufacturing	Aug 16, 2019
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Class I	Anesthesiology	Contract manufacturing	Aug 3, 2018
CAE	Airway, Oropharyngeal, Anesthesiology	Class I	Anesthesiology	Contract manufacturing	Aug 15, 2016
CAT	Cannula, Nasal, Oxygen	Class I	Anesthesiology	Contract manufacturing	Apr 16, 2018
CBH	Device, Fixation, Tracheal Tube	Class I	Anesthesiology	Contract manufacturing	Nov 12, 1992
CCX	Support, Patient Position	Class I	Anesthesiology	Contract manufacturing	Apr 16, 2018
DQY	Catheter, Percutaneous	Class II	Cardiovascular	Contract manufacturing	Jan 28, 2026
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract manufacturing	Jun 15, 2021
DWO	Needle, Biopsy, Cardiovascular	Class I	General and plastic surgery	Contract manufacturing	Dec 22, 2020
DYN	Mouthpiece, Saliva Ejector	Class I	Dental	Contract manufacturing	Oct 21, 2019
DZE	Implant, Endosseous, Root-Form	Class II	Dental	Contract manufacturing	Jul 27, 2018
ECI	Band, Elastic, Orthodontic	Class I	Dental	Contract manufacturing	Aug 15, 1988
EFN	Cotton, Roll	Class I	Dental	Contract manufacturing	Aug 12, 2016
EFW	Toothbrush, Manual	Class I	Dental	Contract manufacturing	Jun 9, 2010
EIE	Dam, Rubber	Class I	Dental	Contract manufacturing	Aug 12, 2016
EIG	Retractor, All Types	Class I	Dental	Contract manufacturing	May 17, 2023
EJL	Bur, Dental	Class I	Dental	Contract manufacturing	Aug 8, 2024
EPE	Brush, Cleaning, Tracheal Tube	Class I	Anesthesiology	Contract manufacturing	Jun 14, 2010
EPP	Splint, Nasal	Class I	Ear, nose and throat	Contract manufacturing	Jun 9, 2010
EPY	Speculum, Ent	Class I	General and plastic surgery	Contract manufacturing	Aug 15, 2016
FCY	Bulb, Inflation, For Endoscope	Class I	Gastroenterology and urology	Contract manufacturing	Mar 1, 2010
FDG	Retractor, Fiberoptic	Class I	Gastroenterology and urology	Contract manufacturing	Jul 13, 2023
FGY	Cannula, Injection	Class I	General and plastic surgery	Contract manufacturing	Jul 7, 2023
FHF	System, Evacuator, Fluid	Class II	Gastroenterology and urology	Contract manufacturing	Sep 28, 2023
FHN	Ligator, Hemorrhoidal	Class II	Gastroenterology and urology	Contract manufacturing	Jun 28, 2019
FKF	Gun, Tie, Dialysis	Class I	Gastroenterology and urology	Contract manufacturing	Apr 16, 2018
FMA	Depressor, Tongue, Non-Surgical	Class I	General hospital	Contract manufacturing	Jul 2, 2015
FMF	Syringe, Piston	Class II	General hospital	Contract manufacturing	Mar 31, 2025
FMH	Container, Specimen, Sterile	Class I	Pathology	Contract manufacturing	Jul 26, 2010
FMP	Protector, Skin Pressure	Class I	General hospital	Contract manufacturing	Sep 14, 2010
FMQ	Restraint, Protective	Class I	General hospital	Contract manufacturing	Aug 25, 2016
FMT	Warmer, Infant Radiant	Class II	General hospital	Contract manufacturing	Jul 6, 2023
FNY	Basin, Emesis	Class I	General hospital	Contract manufacturing	Nov 12, 1992
FOD	Device, Occlusion, Umbilical	Class I	General hospital	Contract manufacturing	Jul 3, 2012
FQM	Bandage, Elastic	Class I	General hospital	Contract manufacturing	Nov 12, 1992
FRL	Fiber, Medical, Absorbent	Class I	General hospital	Contract manufacturing	Nov 12, 1992
FTY	Tape, Measuring, Rulers And Calipers	Class I	General and plastic surgery	Contract manufacturing	Jun 14, 2010
FXG	Specula Accessories	Class I	General and plastic surgery	Contract manufacturing	Nov 26, 2018
FXP	Cover, Shoe, Operating-Room	Class I	General and plastic surgery	Contract manufacturing	Aug 12, 2016
FYH	Splint, Extremity, Noninflatable, External, Sterile	Class I	General and plastic surgery	Contract manufacturing	May 17, 2023
FZZ	Marker, Skin	Class I	General and plastic surgery	Contract manufacturing	Nov 17, 2010
GAX	Tourniquet, Nonpneumatic	Class I	General and plastic surgery	Contract manufacturing	Jun 14, 2010
GAZ	Tubing, Noninvasive	Class II	General hospital	Contract manufacturing	Nov 9, 2007
GBA	Catheter, Balloon Type	Class I	General and plastic surgery	Contract manufacturing	Jul 6, 2021
GBX	Catheter, Irrigation	Class I	General and plastic surgery	Contract manufacturing	Apr 16, 2018
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	Class I	General and plastic surgery	Contract manufacturing	Jan 24, 2019
GDF	Guide, Needle, Surgical	Class I	General and plastic surgery	Contract manufacturing	Dec 3, 2018
GDY	Gauze/Sponge, Internal, X-Ray Detectable	Class I	General and plastic surgery	Contract manufacturing	Nov 12, 1992
GEC	Brush, Scrub, Operating-Room	Class I	General and plastic surgery	Contract manufacturing	Nov 7, 2012
GED	Brush, Dermabrasion, Manual	Class I	General and plastic surgery	Contract manufacturing	Jul 23, 2018
HDF	Speculum, Vaginal, Metal	Class I	Obstetrics and gynecology	Contract manufacturing	Jan 30, 2019
HIB	Speculum, Vaginal, Nonmetal	Class II	Obstetrics and gynecology	Contract manufacturing	Aug 15, 2016
HIC	Speculum, Vaginal, Nonmetal, Fiberoptic	Class II	Obstetrics and gynecology	Contract manufacturing	Jan 30, 2019
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Class I	Ophthalmic	Contract manufacturing	Nov 17, 2010
HOZ	Sponge, Ophthalmic	Class II	Ophthalmic	Contract manufacturing	Apr 16, 2018
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Nov 27, 2018
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Aug 17, 2020
HST	Apparatus, Traction, Non-Powered	Class I	Orthopedic	Contract manufacturing	Aug 3, 2018
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Mar 31, 2025
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Nov 26, 2018
HTX	Rongeur	Class I	Orthopedic	Contract manufacturing	Sep 26, 2023
HWT	Template	Class I	Orthopedic	Contract manufacturing	Dec 4, 2018
HXE	Fork	Class I	Orthopedic	Contract manufacturing	Jan 13, 2026
HXI	Passer, Wire, Orthopedic	Class I	Orthopedic	Contract manufacturing	Dec 3, 2018
ILZ	Accessories, Traction	Class I	Physical medicine	Contract manufacturing	Mar 21, 2013
IPM	Cover, Limb	Class I	Physical medicine	Contract manufacturing	Nov 12, 1992
IWZ	Film, Radiographic	Class I	Radiology	Contract manufacturing	Sep 26, 2018
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Class II	Radiology	Contract manufacturing	May 8, 2018
JAC	System, X-Ray, Film Marking, Radiographic	Class I	Radiology	Contract manufacturing	Nov 17, 2010
JET	Pick, Massaging	Class I	Dental	Contract manufacturing	Apr 16, 2018
JOL	Catheter And Tip, Suction	Class II	General hospital	Contract manufacturing	Jul 1, 2021
JXI	Cuff, Nerve	Class II	Neurology	Contract manufacturing	Mar 20, 2024
KCN	Ear Wick	Class I	Ear, nose and throat	Contract manufacturing	Jan 8, 2025
KDC	Instrument, Surgical, Disposable	Class I	General and plastic surgery	Contract manufacturing	Nov 12, 1992
KDD	Kit, Surgical Instrument, Disposable	Class I	General and plastic surgery	Contract manufacturing	Nov 12, 1992
KDQ	Bottle, Collection, Vacuum	Class II	General hospital	Contract manufacturing	Aug 12, 2016
KET	Filters, Cell Collection, Tissue Processing	Class I	Pathology	Contract manufacturing	Feb 15, 2012
KEW	Slides, Microscope	Class I	Pathology	Contract manufacturing	Jul 8, 2010
KGS	Retention Device, Suture	Class I	General and plastic surgery	Contract manufacturing	Dec 5, 2012
KGX	Tape And Bandage, Adhesive	Class I	General hospital	Contract manufacturing	Nov 17, 2010
KGY	Bag, Intestine	Class I	General and plastic surgery	Contract manufacturing	May 13, 2014
KIZ	Dish, Tissue Culture	Class I	Hematology	Contract manufacturing	Jul 8, 2010
KJG	Tube, Tissue Culture	Class I	Pathology	Contract manufacturing	Jul 8, 2010
KME	Bedding, Disposable, Medical	Class I	General hospital	Contract manufacturing	Jan 28, 2019
KMJ	Lubricant, Patient	Class I	General hospital	Contract manufacturing	Aug 15, 2016
KMK	Device, Intravascular Catheter Securement	Class I	General hospital	Contract manufacturing	Dec 3, 2018
KNW	Instrument, Biopsy	Class II	Gastroenterology and urology	Contract manufacturing	Mar 31, 2025
KPJ	Chamber, Oxygen, Topical, Extremity	Class II	General and plastic surgery	Contract manufacturing	Jul 6, 2023
KXF	Applicator, Absorbent Tipped, Non-Sterile	Class I	General hospital	Contract manufacturing	Nov 12, 1992
KXG	Applicator, Absorbent Tipped, Sterile	Class I	General hospital	Contract manufacturing	Jun 13, 2001
KYW	Container, Liquid Medication, Graduated	Class I	General hospital	Contract manufacturing	Nov 7, 2012
LDE	Stethoscope, Manual	Class I	Cardiovascular	Contract manufacturing	Aug 18, 2011
LLZ	System, Image Processing, Radiological	Class II	Radiology	Contract manufacturing	May 8, 2018
LRP	Tray, Surgical	Class I	General and plastic surgery	Contract manufacturing	Oct 14, 2019
LWK	Razor, Surgical	Class I	General and plastic surgery	Contract manufacturing	Aug 12, 2016
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Oct 29, 2020
LYU	Accessory, Surgical Apparel	Class I	General and plastic surgery	Contract manufacturing	May 24, 2016
LYV	Label Or Tag, Sterile	Class I	General and plastic surgery	Contract manufacturing	Jun 26, 2012
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Dec 3, 2018
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Feb 13, 2015
MNK	Endoscopic Bite Block	Class I	Gastroenterology and urology	Contract manufacturing	Apr 16, 2018
MNL	Accessories, Cleaning Brushes, For Endoscope	Class I	Gastroenterology and urology	Contract manufacturing	Apr 16, 2018
MOQ	Battery, Replacement, Rechargeable	Class I	General and plastic surgery	Contract manufacturing	Mar 29, 2016
MQV	Filler, Bone Void, Calcium Compound	Class II	Orthopedic	Contract manufacturing	Sep 17, 2020
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	Mar 31, 2025
MWS	Stabilizer, Heart	Class I	Cardiovascular	Contract manufacturing	Oct 25, 2012
NAB	Gauze / Sponge,Nonresorbable For External Use	Class I	General and plastic surgery	Contract manufacturing	Apr 2, 2014
NHA	Abutment, Implant, Dental, Endosseous	Class II	Dental	Contract manufacturing	Jul 27, 2018
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Class I	Obstetrics and gynecology	Contract manufacturing	Feb 26, 2021
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	Class I	General hospital	Contract manufacturing	Jun 9, 2010
NWV	Laparoscopic Accessories, Gynecologic	Class I	Obstetrics and gynecology	Contract manufacturing	Feb 26, 2021
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	May 8, 2018
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Class I	Anesthesiology	Contract manufacturing	Aug 9, 2024
OMP	Negative Pressure Wound Therapy Powered Suction Pump	Class II	General and plastic surgery	Contract manufacturing	May 8, 2018
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	Contract manufacturing	Mar 31, 2025
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Aug 25, 2025
OWB	Interventional Fluoroscopic X-Ray System	Class II	Radiology	Contract manufacturing	May 8, 2018
PDQ	Neurosurgical Nerve Locator	Class II	Ear, nose and throat	Contract manufacturing	Mar 31, 2025
PEK	Spinous Process Plate	Class II	Orthopedic	Contract manufacturing	Feb 22, 2022
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class II	Orthopedic	Contract manufacturing	Dec 3, 2018
PLF	Bone Wedge	Class II	Orthopedic	Contract manufacturing	Jun 8, 2021
PUI	Drape, Surgical, Exempt	Class II	General and plastic surgery	Contract manufacturing	Jul 23, 2018
QGQ	Bone Indentation Device	Class II	Orthopedic	Contract manufacturing	Oct 29, 2021
QJP	Catheter, Percutaneous, Neurovasculature	Class II	Cardiovascular	Contract manufacturing	Jan 28, 2026