IWS · Class I · 21 CFR 892.6500

FDA Product Code IWS: Shield, Eye, Radiological

Leading manufacturers include Medtec, Inc., Best Industries and Burkhart Roentgen Intl., Inc..

6
Total
6
Cleared
184d
Avg days
1992
Since

FDA 510(k) Cleared Shield, Eye, Radiological Devices (Product Code IWS)

6 devices
1–6 of 6
Cleared Jun 19, 1995
COATED TUNGSTEN EYESHIELD
K945515
Medtec, Inc.
Radiology · 222d
Cleared Dec 30, 1994
ROYAL MARSDEN GOLD GRAIN GUN
K940119
Best Industries
Radiology · 354d
Cleared Dec 23, 1994
TUNGSTEN EYESHIELD
K943011
Medtec, Inc.
Radiology · 182d
Cleared Feb 22, 1994
MED-GENESIS PATIENT LASER EYE SHIELD
K934459
Med-Genesis, Inc.
Radiology · 165d
Cleared Nov 12, 1993
NUCLEAR ASSOCIATES GLASSERS
K934362
Victoreen, Inc.
Radiology · 65d
Cleared May 28, 1992
RADIOLOGICAL PROTECTIVE EYE SHIELD
K920540
Burkhart Roentgen Intl., Inc.
Radiology · 113d

About Product Code IWS - Regulatory Context