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Data / Medical devices / United States / Life Science Outsourcing, Inc.

Life Science Outsourcing, Inc.: FDA-registered device maker in Brea, CA, United States, 2 510(k) clearances

Life Science Outsourcing, Inc. is registered with the FDA (registration 2031093) in Brea, CA, United States. It lists 61 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 31, 2019. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Life Science Outsourcing, Inc.
FDA registration number
2031093
FEI number
3001236549
Address
830 Challenger Street, Brea, CA, United States, 92821
Owner or operator
Life Science Outsourcing, Inc. (10024857)
Roles
Contract manufacturer, Contract sterilizer, Repackager or relabeler
First device listed
December 3, 2012
Registered through
2026
Brand names listed
7680S Profile 3D Sizer Set, 818-2131 Traverse Rotary Glide Path File - 6/.13/21mm - N, 818-2132 Traverse Rotary Glide Path File - 6/.13/25mm - N, 818-2133 Traverse Rotary Glide Path File - 6/.13/31mm - N, 818-2141 Traverse Orifice and Glide Path File - 6/.13/21mm - N, 818-2142 Traverse Orifice and Glide Path File - 6/.13/25mm - N, 818-2143 Traverse Orifice and Glide Path File - 6/.13/31mm - N, 818-2146 Traverse Orifice and Glide Path File - 6/.13/21mm - R and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Contract manufactureraccessdata.fda.gov
Accessory, Barium Sulfate, Methyl Methacrylate For CranioplastyMYU2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
ArthroscopeHRX2Contract manufactureraccessdata.fda.gov
AwlHWJ1Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Bone CementLOD2Contract manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Contract manufactureraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Contract manufactureraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)KNF2Contract manufactureraccessdata.fda.gov
Confocal Optical ImagingOWN2Repackager or relabeleraccessdata.fda.gov
Container, I.V.KPE2Contract manufactureraccessdata.fda.gov
Device, Anti-SnoringLRK2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Device, Thermal Ablation, EndometrialMNB3Contract manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)HBG2Contract manufactureraccessdata.fda.gov
Electromyograph, DiagnosticIKN2Contract manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract sterilizeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Contract manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Contract manufactureraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Contract sterilizeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Contract sterilizeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract sterilizeraccessdata.fda.gov
Light, Surgical, FiberopticFST2Contract manufactureraccessdata.fda.gov
Low Energy Direct Current Thermal Ablation SystemOAB2Contract sterilizeraccessdata.fda.gov
Marker, SkinFZZ1Contract manufactureraccessdata.fda.gov
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall DefectsOXJ2Contract manufactureraccessdata.fda.gov
Mesh, Surgical, PolymericFTL2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract manufactureraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Contract manufactureraccessdata.fda.gov
Parathyroid Autofluorescence Imaging DeviceQDG2Repackager or relabeleraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Contract manufactureraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerHSX2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
ReamerHTO1Contract manufactureraccessdata.fda.gov
Replacement Heart-ValveDYE3Contract sterilizeraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Contract manufactureraccessdata.fda.gov
Ring, AnnuloplastyKRH2Contract sterilizeraccessdata.fda.gov
Scalpel, One-PieceGDX1Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Sizer, Heart-Valve, ProsthesisDTI1Contract manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Spinous Process PlatePEK2Contract manufactureraccessdata.fda.gov
Splint, Intranasal SeptalLYA1Contract manufactureraccessdata.fda.gov
Stimulator, Electrical, Evoked ResponseGWF2Contract manufactureraccessdata.fda.gov
Stimulator, NerveETN2Contract manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Implanted (Pain Relief)GZB2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
System, Balloon, Intra-Aortic And ControlDSP2Contract manufactureraccessdata.fda.gov
Tap, BoneHWX1Contract manufactureraccessdata.fda.gov
Tube, Gastro-EnterostomyKGC2Contract manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Wound Retraction And Protection SystemPQI2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 31, 2019K190891Fluobeam LXQDGSubstantially EquivalentFluopticsaccessdata.fda.gov
May 7, 2014K132475FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEMOWNSubstantially EquivalentFluopticsaccessdata.fda.gov

Compare with other makers

Updated July 31, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.