Medical device manufacturer
St. Jude Medical, Inc.
St. Jude Medical, Inc. holds 128 FDA 510(k) clearances across 26 product codes. Median elapsed review time is 65 days. openFDA lists 97 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
- 128
- Product codes
- 26
- Median review
- 65 days
- Recall records
- 97
How does FDA spell St. Jude Medical, 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 |
|---|---|---|
| St Jude Medical | device/510k | normalised |
| St Jude Medical | device/recall | normalised |
| St Jude Medical | device/enforcement | normalised |
| St Jude Medical Inc | device/recall | normalised |
| St Jude Medical Inc | device/enforcement | normalised |
| St Jude Medical Inc. | device/recall | normalised |
| St Jude Medical Inc. | device/enforcement | normalised |
| St. Jude Medical | 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 St. Jude Medical, Inc. file in?
26 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DYB | Introducer, Catheter | 26 | 30 days | |
| DQK | Computer, Diagnostic, Programmable | 23 | 68 days | |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 14 | 65 days | |
| DQY | Catheter, Percutaneous | 13 | 111 days | |
| KRH | Ring, Annuloplasty | 10 | 30 days | |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 6 | 92 days | |
| DQX | Wire, Guide, Catheter | 3 | 47 days | |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 3 | 109 days | |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 3 | 98 days | |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 29 days | |
| DRA | Catheter, Steerable | 2 | 107 days | |
| DRC | Trocar | 2 | 28 days | |
| DXO | Transducer, Pressure, Catheter Tip | 2 | 88 days | |
| GXR | Cover, Burr Hole | 2 | 56 days | |
| LDF | Electrode, Pacemaker, Temporary | 2 | 27 days | |
| LLZ | System, Image Processing, Radiological | 2 | 39 days | |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 2 | 30 days | |
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | 2 | 43 days | |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 2 | 36 days | |
| DRB | Stylet, Catheter | 1 | 69 days | |
| DSP | System, Balloon, Intra-Aortic And Control | 1 | 472 days | |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 52 days | |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 | 15 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 30 days | |
| KRA | Catheter, Continuous Flush | 1 | 27 days |
Showing the 25 they file in most, of 26.
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 St. Jude Medical, Inc. had a recall?
openFDA lists 97 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1427-2025Class IIOpen, ClassifiedMOM
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
Z-0987-2025Class IIOpen, ClassifiedMOM
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
Z-0988-2025Class IIOpen, ClassifiedMOM
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Z-0989-2025Class IIOpen, ClassifiedMOM
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Z-2348-2024Class IIOpen, ClassifiedDYB
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Showing the 5 most recently initiated of 97.
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 St. Jude Medical, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K181382 | GuardianTM Burr Hole Cover System | GXR | 56 | |
| K172396 | EnSite Velocity Cardiac Mapping System v5.2 | DQK | 258 | |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | MTD | 258 | |
| K173232 | myMerlin(TM) Mobile Application Model APP1001 | MXC | 29 | |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | MXC | 298 | |
| K162643 | MediGuide Technology System | DQK | 82 | |
| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D | DRF | 309 | |
| K160218 | AutoMark Module | DQK | 319 | |
| K160210 | EnSite Precision Cardiac Mapping System v2.0 | DQK | 320 | |
| K161873 | Pacel Flow Directed Pacing Catheter | LDF | 138 |
Source: openFDA device/510k · retrieved
Where is St. Jude Medical, Inc. registered?
FDA lists 1 registered establishment 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 St. Jude Medical, 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.