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Auxein medical Private limited: FDA-registered device maker in Sonipat Haryana, India, 15 510(k) clearances

Auxein medical Private limited is registered with the FDA (registration 3010303097) in Sonipat Haryana, India. It lists 83 device types. The FDA files 15 510(k) clearances under its listings, the newest dated October 9, 2024. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Auxein medical Private limited
FDA registration number
3010303097
Address
Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area, HSIIDC Sonipat- 131028, Haryana, INDIA, Sonipat Haryana, India, 131028
Owner or operator
Auxein Medical Pvt Ltd (10046810)
Roles
Complaint file establishment, Manufacturer
First device listed
May 16, 2014
Registered through
2026
Brand names listed
1.5mm Container, 2.4 Adjustable Drill Bit, 2.4 Drill Bit, 12mm, 2.4 Drill Bit, 14mm, 2.4 Drill Bit, 16mm, 2.4 mm Radius System, 2.4mm Container, 2.7mm Contaitner and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Complaint file establishment, Manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Complaint file establishment, Manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Single ComponentKTW2Complaint file establishment, Manufactureraccessdata.fda.gov
AwlHWJ1Complaint file establishment, Manufactureraccessdata.fda.gov
Battery, Replacement, RechargeableMOQ1Manufactureraccessdata.fda.gov
Bed, Rocking, Breathing AssistCCO2Manufactureraccessdata.fda.gov
Bit, DrillHTW1Complaint file establishment, Manufactureraccessdata.fda.gov
Blade, ScalpelGES1Manufactureraccessdata.fda.gov
Block, Cutting, Ent, SterileJXS1Manufactureraccessdata.fda.gov
Cabinet, Table And Tray, AnesthesiaBRY1Manufactureraccessdata.fda.gov
ClampHXD1Complaint file establishment, Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufactureraccessdata.fda.gov
CorkscrewHWI1Manufactureraccessdata.fda.gov
CountersinkHWW1Manufactureraccessdata.fda.gov
Crimper, PinHXQ1Manufactureraccessdata.fda.gov
CuretteHTF1Complaint file establishment, Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Manufactureraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Manufactureraccessdata.fda.gov
Dispenser, CementKIH1Manufactureraccessdata.fda.gov
Driver, ProsthesisHWR1Manufactureraccessdata.fda.gov
Dynamometer, NonpoweredHRW1Manufactureraccessdata.fda.gov
ElevatorHTE1Complaint file establishment, Manufactureraccessdata.fda.gov
Evacuator, Vapor, Cement MonomerJDY1Manufactureraccessdata.fda.gov
ExtractorHWB1Manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Complaint file establishment, Manufactureraccessdata.fda.gov
FileHTP1Manufactureraccessdata.fda.gov
ForkHXE1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Goniometer, Ac-PoweredKQX1Manufactureraccessdata.fda.gov
Goniometer, NonpoweredKQW1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Complaint file establishment, Manufactureraccessdata.fda.gov
Halter, Head, TractionHSS1Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Complaint file establishment, Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Manufactureraccessdata.fda.gov
ImpactorHWA1Complaint file establishment, Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufactureraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Manufactureraccessdata.fda.gov
Instrument, Cast Removal, Ac-PoweredLGH1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Complaint file establishment, Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Manufactureraccessdata.fda.gov
Knife, OrthopedicHTS1Manufactureraccessdata.fda.gov
Light, Surgical, ConnectorFSX2Manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Manufactureraccessdata.fda.gov
Nail, Fixation, BoneJDS2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Manufactureraccessdata.fda.gov
OsteotomeHWM1Manufactureraccessdata.fda.gov
PasserHWQ1Manufactureraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Complaint file establishment, Manufactureraccessdata.fda.gov
Positioner, SocketKIL1Manufactureraccessdata.fda.gov
ProbeHXB1Complaint file establishment, Manufactureraccessdata.fda.gov
Punch, Femoral NeckHWP1Manufactureraccessdata.fda.gov
Pusher, SocketHXO1Manufactureraccessdata.fda.gov
ReamerHTO1Complaint file establishment, Manufactureraccessdata.fda.gov
RongeurHTX1Complaint file establishment, Manufactureraccessdata.fda.gov
Scale, PatientFRW1Manufactureraccessdata.fda.gov
Scale, Stand-On, PatientFRI1Manufactureraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Complaint file establishment, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Complaint file establishment, Manufactureraccessdata.fda.gov
Set, Hollow MillHWL1Manufactureraccessdata.fda.gov
Skid, BoneHWO1Manufactureraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Manufactureraccessdata.fda.gov
Splint, TractionHSP1Manufactureraccessdata.fda.gov
Stainer, Tissue, AutomatedKEY1Manufactureraccessdata.fda.gov
Stand, InfusionFOX1Manufactureraccessdata.fda.gov
Staple DriverHXJ1Manufactureraccessdata.fda.gov
Starter, Bone ScrewHWD1Manufactureraccessdata.fda.gov
Stripper, SurgicalHRT1Complaint file establishment, Manufactureraccessdata.fda.gov
TampHXG1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Complaint file establishment, Manufactureraccessdata.fda.gov
TemplateHWT1Complaint file establishment, Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Manufactureraccessdata.fda.gov
TrephineHWK1Manufactureraccessdata.fda.gov
Trocar, Gastro-UrologyFBQ2Manufactureraccessdata.fda.gov
Twister, WireHXS1Manufactureraccessdata.fda.gov
Unit, Traction, Hip, Non-Powered, Non-PenetratingHSR1Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.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
October 9, 2024K240181Clavicle and Scapula SystemHRSSubstantially EquivalentAuxein Medical Pvt., Ltd.accessdata.fda.gov
November 30, 2023K221787Auxein's DHS/DCS Plate SystemKTTSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
January 27, 2023K213059Tibia and Fibula SystemHRSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
December 16, 2022K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorMBISubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
November 18, 2022K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateMBISubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
November 4, 2022K213108Humerus & Ulna SystemHRSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
October 3, 2022K213014Varixis Elbow SystemHRSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
August 22, 2022K213109Auxilock Draw Tight Suture-Based AnchorMBISubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
July 29, 2022K213104Auxilock Titanium Screw-In Suture AnchorMBISubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
March 14, 2022K2113242.4mm Distal Radius SystemHRSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
August 25, 2021K210792Auxein Nailing SystemHWCSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
August 20, 2021K203029Auxilock Titanium Interference ScrewHWCSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
April 6, 2021K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemNKBSubstantially EquivalentAuxein Medical Private Limited/71164accessdata.fda.gov
June 10, 2020K192003Auxein Nailing SystemJDSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
June 30, 2015K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking ScrewsHRSSubstantially EquivalentAuxein Medicalaccessdata.fda.gov

Compare with other makers

Updated October 9, 2024. 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.