ClearanceBrief
Company ยท CA

AMD Medicom Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2020. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
7recalls (2 in 12 months)
7recalls that name a 510(k)

Product codes

CodeDeviceRecords
FXXMask, Surgical5
EFQGauze/Sponge, Internal2
FYCGown, Isolation, Surgical1
OXZPediatric/Child Facemask1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 17, 2020K190306AMD Ritmed AssureWear VersaGown
Amd Medicom, Inc., CA
FYC
Sep 17, 2019K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Proce
Amd Medicom, Inc., CA
OXZ

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 16, 2026AMD Medicom Inc.
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Open, Classified		 EFQK830269
Jun 16, 2026AMD Medicom Inc.
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/
Open, Classified		 EFQK830269
Feb 16, 2024AMD Medicom Inc.
PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Open, Classified		 FXXK051291
Feb 16, 2024AMD Medicom Inc.
HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Open, Classified		 FXXK051291
Feb 16, 2024AMD Medicom Inc.
HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Open, Classified		 FXXK051291
Oct 11, 2019AMD Medicom Inc.
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
Terminated		 FXXK051291
Oct 11, 2019AMD Medicom Inc.
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
Terminated		 FXXK051291
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