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Data / Medical devices / India / Healthium Medtech Limited

Healthium Medtech Limited: FDA-registered device maker in BANGALORE Karnataka, India, 16 510(k) clearances

Healthium Medtech Limited is registered with the FDA (registration 3004944585) in BANGALORE Karnataka, India. It lists 21 device types. The FDA files 16 510(k) clearances under its listings, the newest dated January 4, 2024. Registered through 2026. FDA data exported November 2, 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 Healthium Medtech Limited
FDA registration number
3004944585
Address
472/D, 13TH Cross, 4TH Phase Peenya Industrial Area, BANGALORE Karnataka, India, 560058
Owner or operator
HEALTHIUM MEDTECH LIMITED (9064005)
Roles
Manufacturer, Specification developer
First device listed
February 22, 2006
Registered through
2026
Brand names listed
12.5° Curved Sleeve 1.5mm anchor, 12.5° Curved Sleeve 1.8mm anchor, 25° Curved Sleeve 1.5mm anchor, 25° Curved Sleeve 1.8mm Anchor, ACL Aimer 2 point Lock Knob, ACL Aimer 3 point Lock Knob, ACL Femoral Aimer 5, ACL Femoral Aimer 6 and more

Devices it lists

DeviceProduct codeClassRoleSource
Applier, Surgical, ClipGDO1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Specification developeraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufactureraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Specification developeraccessdata.fda.gov
Gauge, DepthHTJ1Specification developeraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Specification developeraccessdata.fda.gov
Light Source, Photographic, FiberopticFCR2Manufactureraccessdata.fda.gov
Mesh, Surgical, PolymericFTL2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
ProbeHXB1Specification developeraccessdata.fda.gov
ReamerHTO1Specification developeraccessdata.fda.gov
Stripper, SurgicalHRT1Specification developeraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Manufactureraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, ExemptPTX2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Manufactureraccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Manufactureraccessdata.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
January 4, 2024K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorMBISubstantially EquivalentHealthium Medtech Limitedaccessdata.fda.gov
December 28, 2023K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantMBISubstantially EquivalentHealthium Medtech Limitedaccessdata.fda.gov
November 8, 2023K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonMBISubstantially EquivalentHealthium Medtech Limitedaccessdata.fda.gov
August 4, 2023K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open ButtonMBISubstantially EquivalentHealthium Medtech Limitedaccessdata.fda.gov
March 22, 2023K223889Stativ® Knotted UHMWPE Suture AnchorMBISubstantially EquivalentHealthium Medtech Limitedaccessdata.fda.gov
June 9, 2008K081003TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTUREGAMSubstantially EquivalentSutures India Pvt., Ltd.accessdata.fda.gov
June 9, 2008K081002MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTUREGAMSubstantially EquivalentSutures India Pvt., Ltd.accessdata.fda.gov
June 9, 2008K081001PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURENEWSubstantially EquivalentSutures India Pvt., Ltd.accessdata.fda.gov
July 26, 2006K060018TRULENE MESHFTLSubstantially EquivalentSutures India Pvt., Ltd.accessdata.fda.gov
June 3, 2005K041514TRUESILK NON-ABSORBABLE SILK SURGICAL SUTUREGAPSubstantially EquivalentSutures India Private Limitedaccessdata.fda.gov
June 3, 2005K041511TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTUREGAWSubstantially EquivalentSutures India Private Limitedaccessdata.fda.gov
June 2, 2005K041512NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTUREGATSubstantially EquivalentSutures India Private Limitedaccessdata.fda.gov
June 2, 2005K041510TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTUREGARSubstantially EquivalentSutures India Private Limitedaccessdata.fda.gov
April 8, 2005K041515TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTUREGAMSubstantially EquivalentSutures India Private Limitedaccessdata.fda.gov
June 2, 1999K982646AILEE SUTURES AND AILEE NEEDLESGALSubstantially EquivalentMyco Medical Supplies, Inc.accessdata.fda.gov
October 25, 1991K911354STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURESGALSubstantially EquivalentInternacional Farmaceutica, S.A. DE C.V.accessdata.fda.gov

Compare with other makers

Updated January 4, 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.