Life Science Outsourcing, Inc.
Somersworth, NH, US
LIFE SCIENCE OUTSOURCING, INC. appears in FDA device records in Somersworth, NH. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 2
Life Science Outsourcing, Inc., in its own words
Everything in this block is Life Science Outsourcing, Inc.’s own statement, entered by the company after it claimed this page. MDM has not checked any of it, and none of it carries a verified mark.
End-to-End Medical Device Contract ManufacturingLife Science Outsourcing provides comprehensive contract manufacturing services for medical device companies, from early-stage startups to established enterprises. Our FDA-registered facilities in California, New Hampshire, and Costa Rica deliver scalable solutions that grow with your business.With ISO 13485 certification and expertise across assembly, packaging, sterilization, and distribution, we eliminate the complexity of bringing medical devices to market while ensuring regulatory compliance at every step.
- Website
- lso-inc.com
- Founded
- 1997
- Employees
- 51 to 200
- Minimum order
- no minimum
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031093 | 3001236549 | LIFE SCIENCE OUTSOURCING, INC. | 830 Challenger Street, Brea, CA 92821 US | 2026 | and 51 more, listed in full below |
| 1221051 | 1221051 | Life Science Outsourcing | 25 CENTRE RD., SOMERSWORTH, NH 03878 US | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- HWJAwl
- HTWBit, Drill
- LODBone Cement
- GEACannula, Surgical, General & Plastic Surgery
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- HOCClip, Iris Retractor
- KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- KPEContainer, I.V.
- LRKDevice, Anti-Snoring
- MNBDevice, Thermal Ablation, Endometrial
- KIHDispenser, Cement
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- IKNElectromyograph, Diagnostic
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- EKSFile, Pulp Canal, Endodontic
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- HIFInsufflator, Laparoscopic
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- FSTLight, Surgical, Fiberoptic
- FZZMarker, Skin
- FTLMesh, Surgical, Polymeric
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- GABNeedle, Suturing, Disposable
- HAWNeurological Stereotaxic Instrument
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HWQPasser
- HXIPasser, Wire, Orthopedic
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HTOReamer
- DYEReplacement Heart-Valve
- GZTRetractor, Self-Retaining, For Neurosurgery
- KRHRing, Annuloplasty
- GDXScalpel, One-Piece
- HWCScrew, Fixation, Bone
- JXGShunt, Central Nervous System And Components
- DTISizer, Heart-Valve, Prosthesis
- MJISpecimen/Tissue, Identification Orientation
- MQPSpinal Vertebral Body Replacement Device
- LYASplint, Intranasal Septal
- GWFStimulator, Electrical, Evoked Response
- ETNStimulator, Nerve
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
- GAPSuture, Nonabsorbable, Silk
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- DSPSystem, Balloon, Intra-Aortic And Control
- HWXTap, Bone
- KGCTube, Gastro-Enterostomy
- HTNWasher, Bolt Nut
Recall records
No recall records for this company in the ingested FDA data.
Verification record
Verified. Verified and inside the annual cycle.
- Last verified
- Vetted since
- Renewal date
What was checked
- FDA establishment registration checked against the registry: passedFDA establishment registration 1221051, current.
- ISO 13485 certificate confirmed with the issuing registrar: passedNSAI registration MD19.4297, I.S. EN ISO 13485:2016, Life Science Outsourcing, Inc., 830 Challenger Street, Brea, CA 92821; granted 2007-08-23, effective 2024-07-01, expiry 2027-06-30. Somersworth NH site: BSI FM 66316, expiry 2026-11-03.
- Facility confirmed at the stated address: passed830 Challenger Street, Brea, CA 92821: the address on FDA registration 2031093 (contract manufacturer, contract sterilizer) and on NSAI certificate MD19.4297.
- Category capability confirmed by documentation review: passedNSAI MD19.4297 scope: contract manufacture, package testing, cleaning and decontamination, contract moist heat sterilization and validation (ISO 17665-1:2006) and contract EtO sterilization and validation (ISO 11135:2014); ISO/IEC 17025:2017 accredited packaging lab; lso-inc.com/solutions/.
- One completed buyer reference call: passedRecord validated.
- Enforcement history clean in MDM's FDA records, ten year lookback: passedNo recall or enforcement record in MDM's FDA data since 2016-09-13.
Categories
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
This company manages its page
Life Science Outsourcing, Inc. has claimed this page and edits what it says about itself. Membership never changes editorial coverage or vetting outcomes.
Data as of , FDA export datePage updated Source: openFDA, public domain