| Device characteristic |
|
|
| Implantable |
|
|
| Yes |
10 (16) |
Stents such as a biliary stent system for treatment of benign strictures |
| No |
53 (84) |
Weight loss treatments, including software and transient space occupiers |
| Life sustaining |
|
|
| Yes |
0 |
|
| No |
63 (100) |
|
| Clinical use |
|
|
| Neurology |
18 (29) |
Nerve stimulators used for treatment of tremors, headaches, and migraines |
| Gastroenterology and urology |
13 (21) |
Treatments for benign prostatic hyperplasia including ultrasound tissue ablation and embolic devices |
| General and plastic surgery |
10 (16) |
Hemostatic devices |
| Otolaryngology |
5 (8) |
Hearing aids |
| Ophthalmology |
4 (6) |
Nerve stimulators to increase tear production |
| Other |
13 (21) |
Ventilation devices to treat patients with sleep disorders, carbon monoxide poisoning, and hypoxemia |
| Postmarket experience |
|
|
| FDA-required postmarket study |
|
|
| Yes |
1 (2) |
Powered exoskeleton to assist ambulation |
| No |
62 (98) |
Transcatheter aortic valve replacement embolic protection system that failed primary end point of reduction in new lesion volume within protected brain territories |
| Highest recall class |
|
|
| Class I |
0 |
|
| Class II |
6 (10) |
Endoscopic hemostat recalled due to malfunction that could cause delay in hemostasis |
| Class III |
0 |
|
| No recall |
57 (90) |
|
| Used as predicate for 510(k) device |
|
|
| Yes |
32 (51) |
Catheter for balloon aortic valvuloplasty that served as a predicate for 15 510(k)-cleared devices |
| No |
31 (49) |
|
