DeviceClearance

Product code LDD— Cardiovascular

DPD DEFIBRILLATOR

Classification name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device class
Class 2
Regulation
21 CFR 870.5300
Advisory panel
Cardiovascular
Total cleared
166
First cleared
Most recent

Market context for product code LDD

FDA has cleared 166 devices under product code LDD between 1978 and 2021, filed by 70 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LDD

Adverse events under product code LDD

product code LDD
Death
38
Malfunction
522
Total
560

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LDD

1–100 of 166

Data sourced from openFDA. This site is unofficial and independent of the FDA.