Medical device manufacturer
Medtronic, Inc.
Medtronic, Inc. holds 243 FDA 510(k) clearances across 71 product codes. Median elapsed review time is 78 days. openFDA lists 324 recall records naming the company. FDA publishes it under 14 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 243
- Product codes
- 71
- Median review
- 78 days
- Recall records
- 324
How does FDA spell Medtronic, Inc.?
FDA publishes this company under 14 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| MEDTRONIC, INC. | device/registrationlisting | normalised |
| Medtronic | device/enforcement | normalised |
| Medtronic | device/recall | normalised |
| Medtronic | device/510k | normalised |
| Medtronic Inc | device/enforcement | normalised |
| Medtronic Inc | device/recall | normalised |
| Medtronic Inc. | device/enforcement | normalised |
| Medtronic Inc. | device/recall | normalised |
Showing 8 of 14.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Medtronic, Inc. file in?
71 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 31 | 60 days | |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 16 | 62 days | |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 16 | 57 days | |
| DQY | Catheter, Percutaneous | 15 | 80 days | |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 11 | 89 days | |
| DTE | Pulse-Generator, Pacemaker, External | 8 | 28 days | |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 7 | 29 days | |
| DQX | Wire, Guide, Catheter | 6 | 111 days | |
| DSI | Detector And Alarm, Arrhythmia | 6 | 132 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 78 days | |
| DQK | Computer, Diagnostic, Programmable | 5 | 85 days | |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 5 | 183 days | |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 5 | 30 days | |
| LDF | Electrode, Pacemaker, Temporary | 5 | 108 days | |
| NDN | Cement, Bone, Vertebroplasty | 5 | 188 days | |
| FTL | Mesh, Surgical, Polymeric | 4 | 142 days | |
| KRH | Ring, Annuloplasty | 4 | 30 days | |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 28 days | |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 3 | 29 days | |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 3 | 224 days | |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 | 100 days | |
| DYB | Introducer, Catheter | 3 | 88 days | |
| GWM | Device, Monitoring, Intracranial Pressure | 3 | 30 days | |
| HRX | Arthroscope | 3 | 45 days | |
| JOX | Analyzer, Heparin, Automated | 3 | 31 days |
Showing the 25 they file in most, of 71.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Medtronic, Inc. had a recall?
openFDA lists 324 recall records naming this company across its whole history, of which 3 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-1948-2026Class IIOpen, ClassifiedOAD
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
Z-1098-2026Class IIOpen, ClassifiedQAN
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Z-0726-2026Class IIOpen, ClassifiedLWS
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Z-2168-2025Class IIOpen, ClassifiedNVZ
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Z-2169-2025Class IIOpen, ClassifiedNVZ
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Showing the 5 most recently initiated of 324.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Medtronic, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261866 | Concerto Versa Detachable Coil | KRD | 20 | |
| K253530 | Trexon Monofilament Synthetic Absorbable Suture | GAM | 196 | |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | DWF | 91 | |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | DWF | 146 | |
| K253998 | Clearview Intracoronary Shunts | DWF | 39 | |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | DTM | 224 | |
| K251831 | Bio-Medicus Life Support Catheter and Introducer | QHW | 216 | |
| K253511 | Concerto Versa Detachable Coil | KRD | 70 | |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | DQY | 80 | |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | DWF | 58 |
Source: openFDA device/510k · retrieved
Where is Medtronic, Inc. registered?
FDA lists 4 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Medtronic, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.