510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
IZDClass I

Probe, Uptake, Nuclear

21 CFR 892.1320 / Radiology
FDA source (opens on fda.gov)

IZD is the FDA product code for Probe, Uptake, Nuclear, a class I device type, regulated under 21 CFR 892.1320. As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
IZD
Device name
Probe, Uptake, Nuclear
Regulation
21 CFR 892.1320
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
30
Ingested recalls
10

Clearances, product code IZD

By decision year
30 clearances under product code IZD with a decision year between 1976 and 2014, 1992 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code IZD by decision year
YearClearances
19761
19771
19781
19811
19831
19841
19861
19892
19903
19911
19925
19932
19951
19961
19972
19981
19991
20021
20111
20131
20141

Applicants with the most clearances

Product code IZD
Applicants holding the most 510(k) clearances under product code IZD
ApplicantClearances
Neoprobe Corp.5
Care Wise Medical Products Corp.4
Capintec Instruments, Inc.3
Surgiceye GmbH3
Medimatic S.r.l.2
Nuclear Data, Inc.2
Oakfield Instruments, Ltd.2
Radiation Monitoring Devices, Inc.2
Actus, Inc.1
Advanced Medical Research Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order