An unpublished FDA report faults a dozen types of devices that won approval in Europe.
PleuraSeal to seal lung incisions.
Trilucent breast implants.
Stent grafts to repair aortic aneurysms (many manufacturers).
Elbow implant (device not named).
Cardiac constraint devices to treat congestive heart failure (including CorCap).
More than 160 dermal fillers.
Pendra glucose monitor sensor.
At least 12 brands of patent foramen ovale occluders.
CoStar drug-coated stent.
Biofield breast cancer detector.
RoboDoc femur drill.
Zephyr emphysema treatment valve.Source: U.S. Food and Drug Administration