ClearanceBrief

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

PanelCodes510(k)s, 12 moRecalls, 12 mo
Anesthesiology19996183
Cardiovascular304408472
Clinical Chemistry40970183
Clinical Toxicology1801413
Dental28122533
Ear, Nose, Throat1665039
Gastroenterology, Urology435233332
General Hospital268148326
General, Plastic Surgery466354403
Hematology2671345
Immunology2342639
Medical Genetics612
Microbiology4189668
Neurology19220697
Obstetrics/Gynecology180100112
Ophthalmic2434054
Orthopedic242432193
Pathology831223
Physical Medicine18713650
Radiology172475354