Medical device manufacturer
Covidien
Covidien holds 223 FDA 510(k) clearances across 60 product codes. Median elapsed review time is 106 days. openFDA lists 574 recall records naming the company. FDA publishes it under 27 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 223
- Product codes
- 60
- Median review
- 106 days
- Recall records
- 574
How does FDA spell Covidien?
FDA publishes this company under 27 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 |
|---|---|---|
| COVIDIEN | device/registrationlisting | normalised |
| COVIDIEN LLC | device/enforcement | normalised |
| COVIDIEN LLC | device/recall | normalised |
| Covidien | device/registrationlisting | normalised |
| Covidien | device/enforcement | normalised |
| Covidien | device/recall | normalised |
| Covidien | device/510k | normalised |
| Covidien (Dba Medtronic) | device/510k | normalised |
Showing 8 of 27.
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 Covidien file in?
60 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 40 | 78 days | |
| GDW | Staple, Implantable | 27 | 34 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 13 | 32 days | |
| DQA | Oximeter | 10 | 118 days | |
| JOW | Sleeve, Limb, Compressible | 8 | 52 days | |
| JOH | Tube Tracheostomy And Tube Cuff | 7 | 179 days | |
| BTR | Tube, Tracheal (W/Wo Connector) | 6 | 234 days | |
| GAG | Stapler, Surgical | 5 | 119 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 5 | 200 days | |
| NEY | System, Ablation, Microwave And Accessories | 5 | 80 days | |
| CBK | Ventilator, Continuous, Facility Use | 4 | 322 days | |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 4 | 224 days | |
| FZP | Clip, Implantable | 4 | 29 days | |
| GXY | Electrode, Cutaneous | 4 | 159 days | |
| LFL | Instrument, Ultrasonic Surgical | 4 | 115 days | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 4 | 59 days | |
| PNR | Enteral Syringes With Enteral Specific Connectors | 4 | 65 days | |
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 | 211 days | |
| EOX | Esophagoscope (Flexible Or Rigid) | 3 | 121 days | |
| JAK | System, X-Ray, Tomography, Computed | 3 | 125 days | |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 114 days | |
| LLZ | System, Image Processing, Radiological | 3 | 56 days | |
| LZH | Pump, Infusion, Enteral | 3 | 202 days | |
| MSD | Catheter, Hemodialysis, Implanted | 3 | 80 days | |
| ORQ | Mesh, Surgical, Deployer | 3 | 15 days |
Showing the 25 they file in most, of 60.
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 Covidien had a recall?
openFDA lists 574 recall records naming this company across its whole history, of which 9 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-2271-2026Class IIOpen, ClassifiedBZT
Temperature probe devices lack FDA clearance.
Z-2272-2026Class IIOpen, ClassifiedBZT
Temperature probe devices lack FDA clearance.
Z-2273-2026Class IIOpen, ClassifiedBZT
Temperature probe devices lack FDA clearance.
Z-2653-2026Class IIOpen, ClassifiedBTO
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
Z-2261-2026Class IIOpen, ClassifiedJOH
Due to customer complaint regarding incorrect display box labeling.
Showing the 5 most recently initiated of 574.
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 Covidien cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | GAG | 230 | |
| K253984 | Instrument Exit Point on Touch Surgery Aide | SFE | 174 | |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN) | CCK | 224 | |
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT | JOH | 245 | |
| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | BZT | 271 | |
| K250725 | Hugo RAS System | SCV | 268 | |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) | BTR | 258 | |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | BTR | 290 | |
| K241486 | Sofsilk Coated Braided Silk Suture | GAP | 193 | |
| K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | FLL | 223 |
Source: openFDA device/510k · retrieved
Where is Covidien registered?
FDA lists 14 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 Covidien 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.