Importer / authorised agent · Maharashtra · India

Johnson And Johnson Private Limited

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
2,162
Manufacturing
100
Import
2,062
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices103
Class BLow–moderate risk322
Class CModerate–high risk809
Class D (high risk)Highest-risk devices928

CDSCO device licences

MOBILE BEARING HEAD · Class DIMPORT · 2026-04-30

The EMPHASYS Dual Mobility Metal Liners and Mobile Bearings are designed to provide additional stability where there is an unstable joint and are for use in total hip arthroplasty, which is intended to provide increased patient mobility and…

IMP/MD/2025/000222 · from Ireland
Saw Blade · Class BIMPORT · 2026-04-22

The VELYS? OSCILLATING SAW BLADE is an accessory to the Velys Robotic Assisted Solution. The VELYS Robotic-Assisted Solution is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anat…

IMP/MD/2026/000279 · from Germany
Trial Liner · Class BIMPORT · 2026-04-22

The devices are intended to enable implantation of DePuy Synthes prostheses. These are intended for reprocessing in a health care facility setting. No direct clinical benefit is expected from these devices as this benefit is expected to be …

IMP/MD/2026/000283 · from United States
Trial Shell · Class BIMPORT · 2026-04-22

The devices are intended to enable implantation of DePuy Synthes prostheses. These are intended for reprocessing in a health care facility setting. No direct clinical benefit is expected from these devices as this benefit is expected to be …

IMP/MD/2025/000756 · from United States
Knee Replacement System-Tibial Insert · Class DIMPORT · 2026-04-07

The SIGMA Primary Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

IMP/MD/2023/000294 · from Ireland
Knee Replacement System-Femoral · Class DIMPORT · 2026-04-07

The SIGMA Primary Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

IMP/MD/2023/000294 · from United States
Knee Replacement System-Tibial tray · Class DIMPORT · 2026-04-07

The SIGMA Primary Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

IMP/MD/2023/000294 · from Ireland
Replacement System-Tibial Insert · Class DIMPORT · 2026-04-07

The SIGMA Primary Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

IMP/MD/2023/000294 · from Ireland
Knee Replacement System-Femoral · Class DIMPORT · 2026-04-07

The SIGMA Primary Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

IMP/MD/2023/000294 · from Ireland
Knee Replacement System-Tibial Component · Class DIMPORT · 2026-04-07

The SIGMA Primary Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

IMP/MD/2023/000294 · from Ireland
Knee Replacement System-Tibial tray · Class DIMPORT · 2026-04-07

The SIGMA Primary Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

IMP/MD/2023/000294 · from Ireland
ADAPTOR TRIAL · Class BIMPORT · 2026-04-07

The devices are intended to enable the implantation of DePuy Synthes prostheses. These are intended for reprocessing in a health care facility setting. No direct clinical benefit is expected from these devices …

IMP/MD/2025/000756 · from United States
SOLID TRIAL · Class BIMPORT · 2026-04-06

The devices are intended to enable implantation of DePuy Synthes prostheses. These are intended for reprocessing in a health care facility setting. No direct clinical benefit is expected from these devices as this benefit is expected to be …

IMP/MD/2023/000291 · from United States
CTT TRIAL · Class BIMPORT · 2026-04-06

The devices are intended to enable implantation of DePuy Synthes prostheses. These are intended for reprocessing in a health care facility setting. No direct clinical benefit is expected from these devices as this benefit is expected to be …

IMP/MD/2023/000291 · from Ireland
Knee Replacement System-Augment · Class DIMPORT · 2026-04-06

The P.F.C modular plus tibial wedges and P.F.C Sigma femoral augments are indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arth…

IMP/MD/2020/000556 · from United States
Cancellous Bone Screw · Class DIMPORT · 2026-04-06

Cancellous Bone Screws are intended to provide additional stability to implanted orthopaedic devices and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

IMP/MD/2023/000294 · from United States
Knee Replacement System-Femoral · Class DIMPORT · 2026-04-06

The DePuy SIGMA High Performance Partial Knee System is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat an…

IMP/MD/2020/000556 · from United States
Catheter · Class DIMPORT · 2026-04-06

The Biosense Webster QDOT MICRO? Bi-Directional Navigation Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a compati…

IMP/MD/2020/000565 · from United States
Knee Replacement System-Rod · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Femoral · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial tray · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial Insert · Class DIMPORT · 2026-04-06

INDICATIONS FOR USE WITH CEMENT The LCS® COMPLETE? ? P.F.C.® SIGMA® RP Mobile Bearing Total Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis. The RPF and RPS inserts and femoral components are in…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Femoral Stem · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Peripheral Bone Screw · Class DIMPORT · 2026-04-06

SOLUTION SYSTEM Peripheral Bone Screws are intended to provide additional stability to implanted orthopaedic devices and are NOT intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone hea…

IMP/MD/2023/000294 · from United States
Bone Screw-Screw · Class DIMPORT · 2026-04-06

DePuy Bone Screws are indicated for use as an ancillary fixation device to be used with tibial and acetabular components in total knee and hip arthroplasty.

IMP/MD/2020/000556 · from United States
Catheter · Class DIMPORT · 2026-04-06

The Biosense Webster QDOT MICRO? Uni-Directional Navigation Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a compat…

IMP/MD/2020/000565 · from United States
Knee Replacement System-Femoral Rotating Hinge · Class DIMPORT · 2026-04-06

The NOILES Rotating Hinge Knee is indicated for use with PMMA bone cement in primary or revision cases in patients: ? who have reached skeletal maturity and ? for whom the surgeon has decided to resect both cruciate ligaments or whose cruci…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Femoral · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Tissue Sealing device · Class CIMPORT · 2026-04-06

The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp, and dissec…

IMP/MD/2020/000009 · from Mexico
Knee Replacement System-Tibial Wedge · Class DIMPORT · 2026-04-06

The P.F.C modular plus tibial wedges and P.F.C Sigma femoral augments are indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arth…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial Insert · Class DIMPORT · 2026-04-06

INDICATIONS FOR USE WITH CEMENT The LCS® COMPLETE? ? P.F.C.® SIGMA® RP Mobile Bearing Total Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis. The RPF and RPS inserts and femoral components are in…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tbial Insert · Class DIMPORT · 2026-04-06

The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnosti…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial Insert · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial Insert · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Stem · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Bone Screw-Screw · Class DIMPORT · 2026-04-06

DePuy Bone Screws are indicated for use as an ancillary fixation device to be used with tibial and acetabular components in total knee and hip arthroplasty.

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial Component · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial Component · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Rotating Hinge Distal Femoral Augment · Class DIMPORT · 2026-04-06

The NOILES Rotating Hinge Knee is indicated for use with PMMA bone cement in primary or revision cases in patients: ? who have reached skeletal maturity and ? for whom the surgeon has decided to resect both cruciate ligaments or whose cruci…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Stem · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Femoral · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial Insert · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Femoral · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Femoral · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Femoral Stem Bolt · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial Tray · Class DIMPORT · 2026-04-06

The DePuy SIGMA High Performance Partial Knee System is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat an…

IMP/MD/2020/000556 · from United States
Knee Replacement System-Tibial Tray · Class DIMPORT · 2026-04-06

Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support…

IMP/MD/2020/000556 · from United States
BOX TRIAL · Class BIMPORT · 2026-04-06

The devices are intended to enable implantation of DePuy Synthes prostheses. These are intended for reprocessing in a health care facility setting. No direct clinical benefit is expected from these devices as this benefit is expected to be …

IMP/MD/2023/000291 · from Ireland
CONNECTOR · Class BIMPORT · 2026-04-06

The devices are intended to enable implantation of DePuy Synthes prostheses. These are intended for reprocessing in a health care facility setting. No direct clinical benefit is expected from these devices as this benefit is expected to be …

IMP/MD/2023/000291 · from Ireland
Knee System-Femoral (CR) · Class DIMPORT · 2026-04-02

The ATTUNE Total Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

IMP/MD/2023/000475 · from Ireland

Global footprint

Cross-rail

The same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.

No FDA clearances linked — India-domestic footprint.

Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.

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