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

Dc-Defibrillator, Low-Energy, (Including Paddles)

21 CFR 870.5300 / Cardiovascular
FDA source (opens on fda.gov)

LDD is the FDA product code for Dc-Defibrillator, Low-Energy, (Including Paddles), a class II device type, regulated under 21 CFR 870.5300. As of , FDA records hold 166 510(k) clearances under this code, the most recent dated , and 31 recalls.

Classification record

Product code
LDD
Device name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Regulation
21 CFR 870.5300
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
166
Ingested recalls
31

Clearances, product code LDD

By decision year
166 clearances under product code LDD with a decision year between 1978 and 2021, 1991 the highest year at 18.
Show the numbers
510(k) clearances under FDA product code LDD by decision year
YearClearances
19782
19803
19817
19822
19838
198412
198514
19866
19877
19886
198912
199012
199118
199211
19939
19948
19952
19962
19975
19981
20001
20022
20032
20041
20082
20102
20114
20141
20151
20191
20201
20211

Applicants with the most clearances

Product code LDD
Applicants holding the most 510(k) clearances under product code LDD
ApplicantClearances
Physio Control, Inc.18
Cardiotronics, Inc.14
ZOLL Medical Corporation11
Nihon Kohden America Inc8
Life Science Instrumentation, Inc.7
Marquette Electronics, Inc.7
Hewlett-Packard Co.6
Medical Research Laboratories, Inc.5
First Medical Devices Corp.4
Honeywell, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 37 companies shown, in name order