India Medtronic Private Limited
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 106 |
| Class B | Low–moderate risk | 356 |
| Class C | Moderate–high risk | 600 |
| Class D (high risk) | Highest-risk devices | 337 |
CDSCO device licences
The Rist Radial Access Selective Catheter is indicated for the introduction of interventional devices into the peripheral, coronary and neurovasculature. It can be used to facilitate the introduction of diagnostic agents in the neurovascula…
IMP/MD/2026/000309 · from United StatesThe Rist 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neurovasculature. The Rist? 071 Radial Access Guide Catheter is indicated for the introduction of inter…
IMP/MD/2026/000309 · from United StatesSacral neuromodulation therapy provided by the InterStim? system is indicated for the management of the following chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract: overactive bladder, fecal inco…
IMP/MD/2019/000093 · from United StatesSacral neuromodulation therapy provided by the InterStim? system is indicated for the management of the following chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract: overactive bladder, fecal inco…
IMP/MD/2019/000093 · from United StatesThis reservoir is indicated for the subcutaneous infusion of insulin from compatible Medtronic insulin pumps and Medtronic Extended infusion sets. Refer to your Medtronic insulin pump user guide for compatibility.
IMP/MD/2019/000358 · from United StatesThe CPM is intended to continuously measure and automatically maintain the cuff pressure of an endotracheal tube or tracheostomy tube that has been set by the user/clinician during mechanical ventilation. The CPM is intended for use with ad…
IMP/MD/2026/000208 · from MalaysiaThe device is indicated to treat atrial fibrillation (paroxysmal, persistent, and longstanding persistent), atrialflutter, and atrial tachycardia. (updation in he IFU and labels to comply with the new EU MDR R…
IMP/MD/2020/000403 · from United States49313-The Cardioblate surgical ablation pen is intended to create spot or linear lesions in cardiac tissue during cardiac surgery using RF energy for the treatment of cardiac arrhythmias. Any supraventricular arrhythmia (such as atrial fibr…
IMP/MD/2020/000403 · from United StatesThe Avalus Ultra sizers are intended to aid the surgeon in the selection of the optimal size of the Avalus Ultra bioprosthesis.
IMP/MD/2020/000517 · from United StatesThe implantable neurostimulator generates electrical pulses and delivers stimulation through one or more leads as part of a neurostimulation system for pain therapy.
IMP/MD/2019/000040 · from United StatesThe GIA? stapler with Tri?Staple? technology and GIA? cartridge with Tri?Staple? technology have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis. The intended purpose of the …
IMP/MD/2018/000215 · from United StatesThe GIA stapler with Tri?Staple technology and GIA cartridge with Tri?Staple technology have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis. The intended purpose of the devi…
IMP/MD/2018/000215 · from United StatesThe GIA? stapler with Tri?Staple? technology and GIA? cartridge with Tri?Staple? technology have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis. The intended purpose of the …
IMP/MD/2018/000215 · from United StatesThe GIA? stapler with Tri?Staple? technology and GIA? cartridge with Tri?Staple? technology have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis. The intended purpose of the …
IMP/MD/2018/000215 · from United StatesWhen used without cement, CD Horizon? Fenestrated Screws (with or without Sextant? or Longitude? instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc dis…
IMP/MD/2019/000283 · from United StatesThe intended purpose of FlexCath Contour steerable sheath is to provide percutaneous introduction into the vasculature and chambers of the heart, and to facilitate positioning of compatible devices.
IMP/MD/2019/000050 · from United StatesThe LigaSure? Robotically Assisted Surgery (RAS) Maryland Jaw Vessel Sealer/Divider is a bipolar electrosurgical instrument intended for use with the Hugo? RAS System where ligation, and division of vessels, thick tissue (tissue bundles), a…
IMP/MD/2026/000130 · from United StatesThe intended purpose of FlexCath Contour steerable sheath is to provide percutaneous introduction into the vasculature and chambers of the heart, and to facilitate positioning of compatible devices.
IMP/MD/2019/000050 · from United StatesThe NIM 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS? electrode is an accessory intended for providing automat…
IMP/MD/2020/000356 · from Dominican RepublicThis device is intended for use as an intraoperative motor nerve stimulator with the Nerve Integrity Monitor (NIM?).
IMP/MD/2020/000356 · from United StatesThe StraightShot Microdebrider System is designed to accommodate a number of Otorhinolaryngology procedures, including Functional Endoscopic Sinus Surgery (FESS), Adenoidectomy, removal of laryngeal and vocal cord lesions, Rhinoplasty, derm…
IMP/MD/2020/000356 · from United StatesThe IPC? is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical pr…
IMP/MD/2020/000356 · from United StatesThis device is intended for use as an intraoperative motor nerve stimulator with the Nerve Integrity Monitor (NIM?).
IMP/MD/2020/000356 · from Dominican RepublicThe Oto-Flex Burs are indicated for use in middle ear and stapes footplate procedures.
IMP/MD/2020/000356 · from Dominican RepublicThe IPC? is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical pr…
IMP/MD/2020/000356 · from United StatesMedtronic Xomed single use burs are indicated for use in incising or removing bone and tissue during general otorhinolaryngology, head and neck, or otoneurological surgery.
IMP/MD/2020/000356 · from United StatesThe StraightShot Microdebrider System is designed to accommodate a number of Otorhinolaryngology procedures, including Functional Endoscopic Sinus Surgery (FESS), Adenoidectomy, removal of laryngeal and vocal cord lesions, Rhinoplasty, derm…
IMP/MD/2020/000356 · from Dominican RepublicSubdermal electrodes are placed intramuscularly or subcutaneously to stimulate or record electrical signals with the Nerve Integrity Monitor (NIM?).
IMP/MD/2020/000356 · from Dominican RepublicThe Medtronic Steerant super stiff guidewire is intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta. The guidewire is not indicated for use in the coronary or neuro vasculature.
IMP/MD/2026/000072 · from United StatesContour 3D - The sizers are to be used to size a patient's tricuspid valve annulus in order to select the proper size of the Contour 3D annuloplasty ring. Do not use other manufacturers? annuloplasty sizers or sizers from other annuloplasty…
IMP/MD/2020/000517 · from United StatesThe Avalus sizers are intended to aid the surgeon in the selection of the optimal size of the Avalus Bioprosthesis.
IMP/MD/2020/000517 · from United StatesThe sizers are intended to size a patient?s valve anatomy in order to select the appropriate aortic Hancock II Ultra porcine bioprosthesis. They are not intended for use with any other manufacturers? prosthesis or with any other Medtronic p…
IMP/MD/2020/000517 · from United StatesThe 21mm and 25mm OrVil? transoral circular stapler anvil is designed to be used with the corresponding 21mm or 25mm EEA? circular stapler with Tri?Staple? technology. The OrVil? transoral circular stapler anvil and EEA? circular stapler wi…
IMP/MD/2018/000215 · from United StatesThe VersaOne? optical trocar with fixation balloon cannula is indicated for use in general, gynecologic, thoracic and urologic minimally invasive surgical procedures. The intended purpose of the device is to create and maintain a?port of en…
IMP/MD/2019/000254 · from United StatesThe VersaOne? optical trocar with fixation balloon cannula is indicated for use in general, gynecologic, thoracic and urologic minimally invasive surgical procedures. The intended purpose of the device is to create and maintain a?port of en…
IMP/MD/2019/000254 · from United StatesThe omnail femoral nail KGD II instruments is the surgical instrument required to install or remove Omnail Nailing system
IMP/MD/2018/000078 · from ChinaThe Stealth Autoguide? System is a positioning and guidance system intendedfor the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a …
IMP/MD/2025/000772 · from ChinaMonopolar and Bipolar disposable stimulator probes are used to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. Disposable stimulator probes are used for minimally invasive and open…
IMP/MD/2025/000743 · from ChinaThese instruments are indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.
IMP/MD/2025/000743 · from United StatesMonopolar and Bipolar disposable stimulator probes are used to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. Disposable stimulator probes are used for minimally invasive and open…
IMP/MD/2025/000743 · from United StatesSubdermal electrodes are placed intramuscularly or subcutaneously to stimulate or record electrical signals with the NIM-Eclipse. The surface electrodes arc applied directly to the patient?s skin. The return needle electrode is applied sub …
IMP/MD/2025/000743 · from ChinaThis percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. Th…
IMP/MD/2020/000403 · from United StatesArgyle Fistula Cannula is used for gaining vascular access for blood removal and blood reinfusion during dialysis. The needle-stick prevention feature is intended to minimize accidental needle-stick injuries.
IMP/MD/2020/000282 · from JapanThe Amplatz Goose Neck Micro Snare kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extracranial neurovascular anatomy.
IMP/MD/2019/000419 · from United StatesThe Amplatz Goose Neck Snare kit is intended for use in the cardiovascular to retrieve and manipulate foreign bodies.
IMP/MD/2019/000419 · from United StatesThese suction tubes are intended for use in cardiac surgery for the removal of blood at the operative site.
IMP/MD/2020/000403 · from United StatesThe Model 10060 suction tube is intended for use in conjunction with cardiopulmonary bypass surgery. It is used for emptying the chambers of the heart and the pericardium during cardiac procedures. The Model 10061 and Model 10062 suction tu…
IMP/MD/2020/000403 · from United StatesFor use in cardiopulmonary bypass surgery lasting up to 6 hours for delivering cardioplegia solutions, venting the left heart through the aortic root, and aspirating air from the aorta
IMP/MD/2020/000403 · from United StatesThis device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.
IMP/MD/2020/000403 · from United StatesThese cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
IMP/MD/2020/000403 · 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.