Smith & Nephew Healthcare Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 17 |
| Class B | Low–moderate risk | 145 |
| Class C | Moderate–high risk | 214 |
| Class D (high risk) | Highest-risk devices | 62 |
CDSCO device licences
The RENASYS? EDGE Pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
IMP/MD/2026/000284 · from United KingdomThe catheter is used for balloon dilatation of the Eustachian tube (Tuba Eustachii) in the event of an obstructive tube dysfunction.
IMP/MD/2021/000060 · from GermanyThe Kit is intended to put the shoulder in traction during arthroscopic surgeries.
IMP/MD/2021/000007 · from United StatesThe Traction Accessory is indicated for use with the SPIDER2 Limb Positioner and lateral shoulder, wrist, or ankle accessories during surgical procedures to allow adjustable traction.
IMP/MD/2021/000007 · from United StatesSurgical Instruments are indicated for use in orthopedic and general surgery.
IMP/MD/2021/000007 · from United StatesThe Smith+Nephew PLATINUM handpiece is intended for resection of soft and osseous tissue.
IMP/MD/2021/000007 · from United StatesThe CLANCY Flexible Drills are indicated for drilling bone tunnels in the knee and General Surgical Instruments are intended for use in orthopedic and general surgery.
IMP/MD/2021/000007 · from United StatesThe ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone.
IMP/MD/2021/000007 · from United StatesIt is intended for use in surgical procedures where suturing is indicated.
IMP/MD/2021/000007 · from United StatesThese Cannula systems are designed to maintain portals for the insertion and extraction of instruments during arthroscopic surgery.
IMP/MD/2021/000007 · from United StatesThese Cannula systems are designed to maintain portals for the insertion and extraction of instruments during arthroscopic surgery.
IMP/MD/2021/000007 · from United StatesThe Smith & Nephew DYONICS 25 Fluid Management System is intended for use during arthroscopic joint surgery to regulate flow of irrigation fluids to maintain intra-articular pressure for uniform distension and clear visualization of the sur…
IMP/MD/2021/000007 · from United StatesThe DYONICS POWER II Control System is intended for use when used with appropriate procedure-specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities…
IMP/MD/2021/000007 · from United States"The visualization system is intended for use in laparoscopic and arthroscopic surgical procedures. The LENS and LENS 4K Camera Control Unit & Camera Head is used in diagnostic and operative endoscopic procedures such as arthroscopy to pro…
IMP/MD/2021/000007 · from United StatesIt is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).
IMP/MD/2021/000007 · from United StatesThe FASTSEAL 6.0 Wand is intended for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures. It is intended for procedures using normal saline (0.9% NaCl) as the irrigation fluid for the Wand.
IMP/MD/2020/000246 · from United StatesThe film protects the IV insertion site from external environmental contaminants as a physical barrier to liquids, particulate matter and microbial contaminants.
IMP/MD/2020/000566 · from United KingdomThe Q-FIX All-Suture Anchor with Needles is intended for use for the reattachment of soft tissue to bone.
IMP/MD/2019/000479 · from United StatesOPSITE FLEXIGRID Dressings are indicated for:? The management of superficial wounds (e.g.,minor burns, scalds, abrasions, lacerations, and leg ulcers in the final stage of healing).? The protection of skin from friction and external contami…
IMP/MD/2020/000566 · from United KingdomACTICOAT is indicated as an absorbent antimicrobial barrier dressing over partial and full thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, burns, and recipient graft sites. ACTICOAT may be used on infected …
IMP/MD/2020/000566 · from United KingdomACTICOAT Flex 7 is indicated as an antimicrobial barrier dressing over partial and full thickness wounds such as burns, surgical sites, pressure ulcers, venous ulcers and diabetic ulcers. ACTICOAT Flex 7 may be used on infected wounds. Wher…
IMP/MD/2020/000566 · from United KingdomACTICOAT Flex 3 is indicated as an antimicrobial barrier dressing over partial and full thickness wounds such as burns, surgical sites, pressure ulcers, venous ulcers and diabetic ulcers. ACTICOAT Flex 3 may be used on infected wounds. Wher…
IMP/MD/2020/000566 · from United KingdomACTICOAT 7 is indicated as an absorbent antimicrobial barrier dressing over partial and full thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, burns, and recipient graft sites. ACTICOAT 7 may be used on infected woun…
IMP/MD/2020/000566 · from United KingdomPOLARSTEM implants are intended to be used as femoral components in total or partial hip arthroplasty.
IMP/MD/2025/000644 · from SwitzerlandULTRATAPE Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
IMP/MD/2019/000248 · from United StatesThe ULTRA FAST-FIX Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. It is indicated for use in knee meniscal repair and allograft transplantation proced…
IMP/MD/2019/000248 · from United StatesThe ENDOBUTTON Fixation Device is indicated for use in suture fixation of ligaments and tendons in patients requiring ligament or tendon repair. The ENDOBUTTON CL BTB Fixation Device is used for fixation of a bone-tendon-bone graft during o…
IMP/MD/2019/000248 · from United StatesThe Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. It is indicated for use in meniscal repairs and allograft transplant pr…
IMP/MD/2019/000248 · from United StatesThe Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Hip - Hip capsule repair (Acetabular labrum reattachment); Shoulder - Capsular stabilization (Bankart repair…
IMP/MD/2019/000248 · from United StatesTWINFIX Ultra HA Preloaded Suture Anchors are intended for use only for the reattachment of soft tissue to bone for the following indications: Shoulder - Bankart lesion repairs, SLAP lesion repairs, Acromioclavicular separation repairs, Rot…
IMP/MD/2019/000248 · from United StatesTWINFIX Ultra Ti Preloaded Suture Anchors are indicated for use only for the reattachment of soft tissue to bone for the following indications: Shoulder (Rotator cuff tear repairs), Knee ( Extra-capsular repairs: Medial collateral ligament,…
IMP/MD/2019/000248 · from United StatesThe Smith & Nephew TWINFIX Ultra PK Preloaded Suture Anchors are indicated for use only for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff tear repairs. Foot and Ankle: Achilles tendon repairs/…
IMP/MD/2019/000248 · from United States"The BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Hip - Acetabular labrum reattachment; Shoulder - Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP…
IMP/MD/2019/000248 · from United StatesThe BIOSURE REGENESORB Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications: Knee - ACL repairs, PCL repairs, Extra-capsular repairs (Medial collateral liga…
IMP/MD/2019/000248 · from United StatesThe HEALICOIL REGENESORB Suture Anchors are intended for use only for the reattachment of soft tissue to bone for the procedures in the Indications for Use section of this document.
IMP/MD/2019/000248 · from United StatesThe Smith & Nephew FOOTPRINT Ultra PK Suture Anchors are indicated for use only for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff tear repairs, Biceps tenodesis
IMP/MD/2019/000248 · from United StatesThe Smith & Nephew MICRORAPTOR REGENESORB Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the procedures in the Indications for Use section of this document.
IMP/MD/2019/000248 · from United StatesThe Smith & Nephew Suture Washers are indicated for use as a fixation point for sutures used in orthopedic ligament repair.
IMP/MD/2019/000248 · from United StatesSmith & Nephew RCI Fixation Screws are used for interference fixation of bone-tendon-bone or soft tissue grafts in anterior or posterior cruciate ligament reconstruction.
IMP/MD/2019/000248 · from United StatesThe Smith & Nephew SOFTSILK Screws are used for interference fixation of bone-tendon-bone or soft tissue grafts in anterior cruciate ligament reconstruction.
IMP/MD/2019/000248 · from United StatesThe Smith & Nephew HEALICOIL PK Preloaded Suture Anchors are indicated for use only for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff tear repairs, Biceps tenodesis. Hip: Gluteal tendon repair…
IMP/MD/2019/000248 · from United StatesThey are indicated for fixation of bone-tendon-bone or soft tissue grafts in anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures.
IMP/MD/2019/000248 · from United StatesThe Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications: Hip - Hip capsule repair (Acetabular labrum repair/reconstruction); Shoulder - Capsular stabilization…
IMP/MD/2019/000248 · from United States"The BIOSURE PK Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9 mm or less and a length of 25 mm or les…
IMP/MD/2019/000248 · from United States"The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures."
IMP/MD/2019/000248 · from United StatesTWINFIX Ti Preloaded Suture Anchors are indicated for use only for the reattachment of soft tissue to bone for the following indications: Shoulder (Bankart lesion repairs, SLAP lesion repairs, Rotator cuff tear repairs, Capsular shift or ca…
IMP/MD/2019/000248 · from United StatesThe Q-FIX? ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle ? Medial or lateral instability repairs/reconstructions ? Achilles tendon repairs/reconstructions
IMP/MD/2019/000479 · from United StatesThe FOOTPRINT? MINI PK, 3.5 mm Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle ? Medial or lateral instability repairs/reconstructions ? Achilles tendon repairs/recon…
IMP/MD/2019/000479 · from United StatesThe ULTRABRIDGE? Kit is intended for use only for the reattachment of soft tissue to bone for the following indications: Foot and Ankle ? Achilles tendon repairs/reconstructions
IMP/MD/2019/000479 · from Costa RicaThe HEALICOIL? PK Suture Anchor with Needles are intended for use only for the reattachment of soft tissue to bone for the following indications: Foot and Ankle ? Medial or lateral instability repairs/reconstructions ? Achilles tendon repai…
IMP/MD/2019/000479 · from Costa RicaGlobal 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.