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Data / Medical devices / China / Canwell Medical Co., Ltd.

Canwell Medical Co., Ltd.: FDA-registered device maker in Jinhua Zhejiang, China, 1 510(k) clearance

Canwell Medical Co., Ltd. is registered with the FDA (registration 3006395932) in Jinhua Zhejiang, China. It lists 42 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 24, 2025. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Canwell Medical Co., Ltd.
FDA registration number
3006395932
Address
No. 466, South Xianhua Street., High-Tech Industrial Zone, Jinhua Zhejiang, China, 321016
Owner or operator
Canwell Medical Co., Ltd. (10024685)
Roles
Contract manufacturer, Manufacturer
First device listed
February 19, 2008
Registered through
2026
Brand names listed
1.5/2/2.4 Plates, 1.5/2/2.4/3.5 Cortex Screws, 1.5/2/2.4/3.5 Locing Screws, 2.5/3/3.5/4/4.5/5/6.5 Headless Compression Screw, 3.5 Calcaneal Plate, INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufactureraccessdata.fda.gov
CaliperKTZ1Contract manufactureraccessdata.fda.gov
Cerclage, FixationJDQ2Contract manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Contract manufactureraccessdata.fda.gov
ClampHXD1Contract manufactureraccessdata.fda.gov
Driver, ProsthesisHWR1Contract manufactureraccessdata.fda.gov
ExtractorHWB1Contract manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufactureraccessdata.fda.gov
ImpactorHWA1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Mesh, Surgical, Acetabular, Hip, ProsthesisJDJ2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Contract manufactureraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerKWZ2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Femoral Component, Cemented, MetalJDG2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal BallLZY2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedLWJ2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateMEH2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousMBL2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerNPJ2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerHSX2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerKRR2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/PolymerKRQ2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufactureraccessdata.fda.gov
ReamerHTO1Contract manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
Tap, BoneHWX1Contract manufactureraccessdata.fda.gov
TemplateHWT1Contract 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
April 24, 2025K242973CanMINI Hand and Foot SystemHRSSubstantially EquivalentCanwell Medical Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated April 24, 2025. 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.