510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LDEClass I

Stethoscope, Manual

21 CFR 870.1875 / Cardiovascular
FDA source (opens on fda.gov)

LDE is the FDA product code for Stethoscope, Manual, a class I device type, regulated under 21 CFR 870.1875. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LDE
Device name
Stethoscope, Manual
Regulation
21 CFR 870.1875
Device class
Class I
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
28
Ingested recalls
0

Clearances, product code LDE

By decision year
28 clearances under product code LDE with a decision year between 1978 and 1994, 1980 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LDE by decision year
YearClearances
19781
19805
19811
19822
19831
19852
19862
19871
19881
19892
19914
19922
19944

Applicants with the most clearances

Product code LDE
Applicants holding the most 510(k) clearances under product code LDE
ApplicantClearances
Conphar, Inc.3
Cher Mel Corp.2
3M Company1
Abco Dealers, Inc.1
American Diagnostic Corp.1
Anup Chakraborty Co.1
Atlas Medical Products LLC1
Bhs Intl., Inc.1
Cypress Medical Products LLC1
D.R.G.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 176 companies shown, in name order