510(k) and recall insights
Views across all FDA 510(k) clearances and device recalls, rebuilt after every daily sync.
| Medical device recalls by FDA device class How recalls split across Class I, II and III devices, the recall-to-clearance ratio per class, and the product codes with the most recalls in each. |
| Recalls within a year of 510(k) clearance The latest device recalls that name a 510(k) cleared less than 12 months before the recall, with the time between the two. |
| Most recalled device types by review panel For each FDA review panel, the product codes with the most recalls of all time and in the last 12 months. |
| Top 510(k) applicants in the last 12 months The 100 companies with the most FDA 510(k) clearances in the last 12 months, with their all-time clearances and recalls. |
| Latest recalls of Class III devices The 100 newest FDA recalls of Class III (highest risk) device types, by product code, with the 510(k)s they name. |
| Latest recalls of Class II devices The 100 newest FDA recalls of Class II device types, by product code, with the 510(k)s they name. |
| Latest recalls of Class I devices The 100 newest FDA recalls of Class I (lowest risk) device types, by product code, with the 510(k)s they name. |
| Companies with the most medical device recalls The 100 companies with the most FDA device recalls, how many of those recalls name a 510(k), and their clearance counts. |
By review panel
| Panel | Codes | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|
| Anesthesiology | 199 | 96 | 183 |
| Cardiovascular | 304 | 408 | 472 |
| Clinical Chemistry | 409 | 70 | 183 |
| Clinical Toxicology | 180 | 14 | 13 |
| Dental | 281 | 225 | 33 |
| Ear, Nose, Throat | 166 | 50 | 39 |
| Gastroenterology, Urology | 435 | 233 | 332 |
| General Hospital | 268 | 148 | 326 |
| General, Plastic Surgery | 466 | 354 | 403 |
| Hematology | 267 | 13 | 45 |
| Immunology | 234 | 26 | 39 |
| Medical Genetics | 6 | 1 | 2 |
| Microbiology | 418 | 96 | 68 |
| Neurology | 192 | 206 | 97 |
| Obstetrics/Gynecology | 180 | 100 | 112 |
| Ophthalmic | 243 | 40 | 54 |
| Orthopedic | 242 | 432 | 193 |
| Pathology | 83 | 12 | 23 |
| Physical Medicine | 187 | 136 | 50 |
| Radiology | 172 | 475 | 354 |