DeviceClearance

Product code DSH— Cardiovascular

Carnation Ambulatory Monitor

Classification name
Recorder, Magnetic Tape, Medical
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Total cleared
195
First cleared
Most recent

Market context for product code DSH

FDA has cleared 195 devices under product code DSH between 1976 and 2026, filed by 121 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 DSH

Adverse events under product code DSH

product code DSH
Death
3
Injury
652
Total
655

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 DSH

1–100 of 195

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