KPY · Class I · 21 CFR 892.6500

FDA Product Code KPY: Shield, Protective, Personnel

Leading manufacturers include Davis Lead Aprons, Inc., Moti Enterprises, Inc. and Infab Corp..

25
Total
25
Cleared
77d
Avg days
1978
Since

FDA 510(k) Cleared Shield, Protective, Personnel Devices (Product Code KPY)

25 devices
1–24 of 25
Cleared Jun 24, 2011
DISPOSABLE THYROID COLLAR
K110900
Bloxr Corporation
Radiology · 85d
Cleared Oct 01, 1996
INTRA-ORAL THERMOPLASTIC SHIELD
K962622
Medtec, Inc.
Radiology · 88d
Cleared Dec 21, 1995
THERMOPLASTIC SHIELD
K954456
Medtec, Inc.
Radiology · 87d
Cleared Dec 06, 1995
UTK-DTE AUTILARY SHIELD
K954146
Mallinckrodt Medical
Radiology · 92d
Cleared Sep 26, 1995
AUKULYTE
K953610
Aukland Medical Plastics, Inc.
Radiology · 55d
Cleared Apr 10, 1995
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
K951004
Kenex , Ltd.
Radiology · 54d
Cleared Apr 03, 1995
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
K951003
Kenex , Ltd.
Radiology · 47d
Cleared Mar 16, 1994
STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
K940539
Standard Imaging, Inc.
Radiology · 37d
Cleared Oct 07, 1993
MAVIG ANGIO SHIELD MODELS 6290 & 6272
K934206
F. Walter Hanel GmbH
Radiology · 38d
Cleared Mar 18, 1992
DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS
K912326
Davis Lead Aprons, Inc.
Radiology · 299d
Cleared Mar 18, 1992
DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.
K912327
Davis Lead Aprons, Inc.
Radiology · 299d
Cleared Mar 18, 1992
DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS
K912378
Davis Lead Aprons, Inc.
Radiology · 294d
Cleared May 01, 1990
RADIATION PROTECTION GLASSES
K900970
Infab Corp.
Radiology · 60d
Cleared Dec 22, 1989
DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL
K896511
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 38d
Cleared Dec 14, 1989
RADIATION PROTECTION APRON
K896289
Infab Corp.
Radiology · 44d
Cleared May 08, 1987
PERSONNEL PROTECTIVE SHIELD
K871502
Cis-Us, Inc.
Radiology · 21d
Cleared Dec 17, 1984
VENTIBOX
K844160
Syncor Intl. Corp.
Radiology · 54d
Cleared Jul 02, 1981
KRYPTON CART
K811677
Medi-Physics Inc. Dba Nycomed Amersham Imaging
Radiology · 17d
Cleared May 27, 1981
BYPASS COIL
K811068
G.D. Searle and Co.
Radiology · 40d
Cleared Feb 12, 1981
MOTI APRON
K810095
Moti Enterprises, Inc.
Radiology · 29d
Cleared Oct 31, 1980
MOTI PROTECTIVE X-RAY MASK
K802377
Moti Enterprises, Inc.
Radiology · 31d
Cleared Oct 26, 1979
FLOW MEDICAL X-RAY PROTECTIVE GLOVES
K791522
Flow X-Ray Corp.
Radiology · 77d
Cleared Apr 23, 1979
GONAD SHIELD
K790639
The Mochlett Laboratories, Inc.
Radiology · 24d
Cleared Jan 26, 1979
APRON, LEADED VINYL
K790080
Pinnacle Distributors, Inc.
Radiology · 14d

About Product Code KPY - Regulatory Context