Johnson And Johnson Private Limited
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 103 |
| Class B | Low–moderate risk | 322 |
| Class C | Moderate–high risk | 809 |
| Class D (high risk) | Highest-risk devices | 928 |
CDSCO device licences
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 IrelandThe 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 GermanyThe 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 StatesThe 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 StatesThe 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 IrelandThe 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 StatesThe 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 IrelandThe 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 IrelandThe 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 IrelandThe 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 IrelandThe 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 IrelandThe 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 StatesThe 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 StatesThe 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 IrelandThe 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 StatesCancellous 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 StatesThe 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 StatesThe 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 StatesTotal 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 StatesTotal 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 StatesTotal 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 StatesINDICATIONS 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 StatesTotal 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 StatesSOLUTION 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 StatesDePuy 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 StatesThe 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 StatesThe 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 StatesTotal 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 StatesThe 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 MexicoThe 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 StatesINDICATIONS 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 StatesThe 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 StatesTotal 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 StatesTotal 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 StatesTotal 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 StatesDePuy 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 StatesTotal 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 StatesTotal 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 StatesThe 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 StatesTotal 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 StatesTotal 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 StatesTotal 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 StatesTotal 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 StatesTotal 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 StatesTotal 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 StatesThe 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 StatesTotal 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 StatesThe 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 IrelandThe 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 IrelandThe 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 IrelandGlobal footprint
Cross-railThe 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.