Marker, Skin
General, Plastic Surgery · 21 CFR 878.4660
Recent MDR events
185 adverse event reports on file
- INKRIGHTNov 12, 2025InjuryBeekley Corporation9021987-2025-00002
- BIONIX ACCU-TATTFeb 11, 2025InjuryBionix, Llc.MW5165901
- SKIN MARKERAug 23, 2023MalfunctionKey Surgical, Llc2183785-2023-00002
- BELKYRA SKIN GRIDJul 25, 2023InjuryAllergan (irvine)2024601-2023-00004
- BELKYRA SKIN GRIDJul 24, 2023InjuryAllergan (irvine)2024601-2023-00005
- RICHARD ALLEN REGULAR TIP PEN W/ RULER AND 6-UP LABELSJun 2, 2023MalfunctionAspen Surgical Products, Caledonia3002750084-2023-00015
- RICHARD ALLEN REGULAR TIP PEN W/ RULER AND 6-UP LABELSJun 1, 2023MalfunctionAspen Surgical Products, Caledonia0001836161-2023-00015
- KYBELLA SKIN GRIDMar 14, 2023InjuryAllergan (irvine)2024601-2023-00001
- KYBELLA SKIN GRIDMar 14, 2023InjuryAllergan (irvine)2024601-2023-00002
- KYBELLA SKIN GRIDMar 14, 2023InjuryAllergan (irvine)2024601-2023-00003
Event type breakdown
Recalls
2 recall events for this product code
- Precision Dynamics CorporationTerminatedAug 2, 2013
Non-sterile Viscot Surgical Skin Markers
PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.
Z-1872-2013 · View FDA record ↗ - Viscot Medical LLCTerminatedMar 29, 2013
Dual Tip Marker, Sterile
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
Z-1025-2013 · View FDA record ↗
Registered firms
189 firms currently registered for this product code
Innovize
North Oaks, MN, US
Rmac Surgical Inc
Etobicoke Ontario, CA
Fetzer Surgical, Llc
Scottsdale, AZ, US
Cardinal Health
Hazelwood, MO, US
Weifang Dragonfly Electronic Technology Co., Ltd.
Weifang Shandong, CN
Suzhou Meccan Import And Export Corp.
Suzhou Jiangsu, CN
Gri Medical & Electronic Technology Co., Ltd.
JIAXING Zhejiang, CN
Medetz Surgical Instruments
Jupiter, FL, US
Scanlan International, Inc.
Saint Paul, MN, US
Anholt Technologies Inc.
Avondale, PA, US
Phoenix Instruments, Inc.
Lisle, IL, US
Suzhou Pipi Medical Products Co.,ltd
Suzhou Jiangsu, CN
Batrik Medical Manufacturing Inc.
Lachine Quebec, CA
Bauer Und Haselbarth-chirurg Gmbh
ELLERAU Schleswig-Holstein, DE
Br Surgical Llc
Jacksonville, FL, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Sterigenics Us Llc
Grand Prairie, TX, US
Veenak International Limited
BIRMINGHAM, GB
Dms Holdings, Inc.,
Waukegan, IL, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Allmed Medical Products Co., Ltd.
ZHIJIANG CITY Hubei, CN
Swantia Medical Private Limited
Sialkot Punjab, PK
My Medical Store Llc
Fort Lauderdale, FL, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
510(k) clearances
23 clearances for this product code
- Surgichip, Inc.Nov 9, 2004
K042555 · SURGICHIP TAG SURGICAL MARKER
- American Medical Mfg., Inc.May 14, 1992
K915066 · DISPOSABLE SKIN MARKER
- Freckles Publications, Inc.Apr 21, 1992
K914759 · BLOOM TRANSPARENT STENCIL
- West Texas Lighthouse For the BlindNov 7, 1991
K912730 · ROCKET SURGICAL SKIN MARKING PEN
- Aesculap, Inc.Feb 6, 1991
K905143 · SKIN MARKER
- Qualtex, Inc.Dec 13, 1990
K904559 · QUALTEX SKIN MARKER
- Westmark, Sterile Packing Systems, Inc. (Sps)Dec 27, 1989
K896792 · SURGICAL SKIN MARKER
- Myocure, Inc.Nov 17, 1986
K864371 · SURGICAL SKIN MARKER