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
IWSClass I

Shield, Eye, Radiological

21 CFR 892.6500 / Radiology
FDA source (opens on fda.gov)

IWS is the FDA product code for Shield, Eye, Radiological, a class I device type, regulated under 21 CFR 892.6500. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IWS
Device name
Shield, Eye, Radiological
Regulation
21 CFR 892.6500
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
6
Ingested recalls
0

Clearances, product code IWS

By decision year
6 clearances under product code IWS with a decision year between 1992 and 1995, 1994 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code IWS by decision year
YearClearances
19921
19931
19943
19951

Applicants with the most clearances

Product code IWS
Applicants holding the most 510(k) clearances under product code IWS
ApplicantClearances
Medtec LLC2
Best Industries1
Burkhart Roentgen Intl., Inc.1
Med-Genesis, Inc.1
Victoreen, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 55 companies shown, in name order