Stryker India Pvt. Ltd.,
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 7 |
| Class B | Low–moderate risk | 133 |
| Class C | Moderate–high risk | 242 |
| Class D (high risk) | Highest-risk devices | 27 |
CDSCO device licences
The device Insufflator 50L is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, Pediatric and Bariatric operating modes of the device are …
IMP/MD/2023/000192 · from GermanyAlphaVent Suture Anchors are intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip. It is indicated for use in the following procedures: Shoulder: Rotator Cuff Repair, Ban…
IMP/MD/2018/000273 · from United States? Painful disabling joint disease of the hip resulting from degenerative arthritis rheumatoid arthritis posttraumatic arthritis or late stage avascular necrosis. ? Revision of previous unsuccessful femoral head replacement, cup arthroplasty…
IMP/MD/2019/000088 · from United StatesSuperadius Total Knee System is intended for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia, and patella to relieve pain, instability, and the restriction of motion due to degenerative bone d…
IMP/MD/2021/000229 · from China? Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. ?Revision of previous unsuccessful femoral head replacement, cup arthropl…
IMP/MD/2020/000112 · from United StatesHOWMEDICA OSTEONICS Torx Cancellous Bone Screws are intended for supplemental fixation of associated HOWMEDICA OSTEONICS cementless Acetabular Shells
IMP/MD/2020/000112 · from United StatesThe Stryker C2C System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue for the placement of screws, wires, pins, plates, and other fixation devices in a variety of su…
IMP/MD/2023/000470 · from United StatesThe Stryker CD NXT Handpiece is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue for the placement of screws, wires, pins, plates, and other fixation devices in a variety…
IMP/MD/2023/000275 · from United StatesThe Stryker C2C System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue for the placement of screws, wires, pins, plates, and other fixation devices in a variety of su…
IMP/MD/2023/000275 · from United StatesThe SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
IMP/MD/2023/000405 · from United StatesPainful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traumat…
IMP/MD/2020/000112 · from United StatesPainful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traumat…
IMP/MD/2020/000112 · from United StatesInstrumentation consists of manual surgical instruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries. Generic, hand-held orthopaedic instrumentation examples include but are not limited to retractors, inserters…
IMP/MD/2020/000112 · from United StatesInstruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries
IMP/MD/2020/000112 · from United StatesInstrumentation consists of manual surgical instruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries. Generic, hand-held orthopaedic instrumentation examples include but are not limited to retractors, inserters…
IMP/MD/2020/000112 · from United StatesInstrumentation consists of manual surgical instruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries. Generic, hand-held orthopaedic instrumentation examples include but are not limited to retractors, inserters…
IMP/MD/2020/000112 · from United StatesInstrumentation consists of manual surgical instruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries. Generic, hand-held orthopaedic instrumentation examples include but are not limited to retractors, inserters…
IMP/MD/2020/000112 · from United StatesThe instruments provided are intended to be used in orthopaedic implant surgeries. The clinical benefit of the instruments is the facilitation of implantation and/or explantation of the orthopaedic implants
IMP/MD/2020/000112 · from United StatesInstrumentation consists of manual surgical instruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries. Generic, hand-held orthopaedic instrumentation examples include but are not limited to retractors, inserters…
IMP/MD/2020/000112 · from United StatesInstrumentation consists of manual surgical instruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries. Generic, hand-held orthopaedic instrumentation examples include but are not limited to retractors, inserters…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. ? Revision of previous unsuccessful femoral head replacement, cup arthro…
IMP/MD/2020/000112 · from United StatesInstrumentation consists of manual surgical instruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries. Generic, hand-held orthopaedic instrumentation examples include but are not limited to retractors, inserters…
IMP/MD/2020/000112 · from United StatesInstrumentation consists of manual surgical instruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries. Generic, hand-held orthopaedic instrumentation examples include but are not limited to retractors, inserters…
IMP/MD/2020/000112 · from United StatesInstrumentation consists of manual surgical instruments intended for use during hip, knee and osteosyntheses orthopaedic surgeries. Generic, hand-held orthopaedic instrumentation examples include but are not limited to retractors, inserters…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United States? Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis; ? Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United States:? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Posttraum…
IMP/MD/2020/000112 · from United States? Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis; ? Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United States? Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis; ? Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United States? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. ? Post-traum…
IMP/MD/2020/000112 · from United StatesIt is intended for use in patients requiring extensive reconstruction of the hip joint and/or Knee joint, including knee fusions, necessitated by extensive bone loss due to trauma, failed previous prosthesis and / or tumor resection
IMP/MD/2020/000112 · from United StatesIt is indicated in conditions such as femoral head/neck fractures or non?unions, aseptic necrosis of the femoral head, osteo, rheumatoid and post, traumatic arthritis of the hip with minimal acetabular involvement or distortion
IMP/MD/2020/000112 · from United StatesIt is intended for use for total hip arthroplasty in conditions such as painful, disabling joint disease of the hip resulting from degenerative arthritis, rheumatoid arthritis , post traumatic arthritis or late stage avascular necr…
IMP/MD/2020/000112 · from United StatesIt is intended for use for total hip arthroplasty in conditions such as painful, disabling joint disease of the hip resulting from degenerative arthritis, rheumatoid arthritis , post traumatic arthritis or late stage avascular necr…
IMP/MD/2020/000112 · from United StatesIt is indicated for use total hip arthroplasty in conditions such as painful , disabling joint disease of the hip resulting from degenerative arthritis , rheumatoid arthritis post ? traumatic arthritis or late stage avascular ne…
IMP/MD/2020/000112 · from United StatesIt is indicated in painful ,disabling joint disease of the hip resulting from degenerative arthritis , rheumatoid arthritis , post-traumatic arthritis or late stage avascular necrosis, revision of previous unsuccessful femoral head r…
IMP/MD/2020/000112 · from United StatesAcetabular Wedges are intended for use : ? As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies. 1) Acetabular Augments are intended for cementless use only to the bone inte…
IMP/MD/2020/000112 · from United StatesIt is indicated for use total hip arthroplasty in conditions such as painful , disabling joint disease of the hip resulting from degenerative arthritis , rheumatoid arthritis post ? traumatic arthritis or late stage avascular ne…
IMP/MD/2020/000112 · from United StatesPainful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. ? Post-traumatic loss of knee joint configuration and function. ? Moderate varus, valgus, or flexion defo…
IMP/MD/2019/000088 · from IrelandPainful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. ? Revision of previous unsuccessful femoral head replacement, cup arthroplas…
IMP/MD/2019/000088 · from IrelandGeneral Total Knee Arthroplasty (TKR) Indications: ? Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid…
IMP/MD/2019/000088 · from IrelandPainful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty…
IMP/MD/2019/000088 · from United StatesGlobal 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.