System, Skin Closure
General, Plastic Surgery · 21 CFR 878.4320
Recent MDR events
11 adverse event reports on file
- DERMACLOSEMay 27, 2025InjuryBaxter Healthcare Corporation1416980-2025-03062
- DERMACLOSEMay 23, 2025InjuryBaxter Healthcare Corporation1416980-2025-03014
- DERMACLOSEMay 23, 2025InjuryBaxter Healthcare Corporation1416980-2025-03018
- NINov 8, 2023InjuryBaxter Healthcare Corporation1416980-2023-05775
- DERMACLOSESep 19, 2023InjuryBaxter Healthcare Corporation1416980-2023-04737
- BANDGRIPMay 2, 2022InjuryBandgrip Inc.MW5109480
- NIMay 24, 2021InjuryBaxter Healthcare Corporation1416980-2021-03113
- NIMay 24, 2021InjuryBaxter Healthcare Corporation1416980-2021-03114
- NIMay 19, 2021InjuryBaxter Healthcare Corporation1416980-2021-03059
- NIMay 19, 2021InjuryBaxter Healthcare Corporation1416980-2021-03060
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
30 firms currently registered for this product code
Inventorr Md Inc
Toronto Ontario, CA
Ningbo Hysent Medical Technology Co., Ltd
Ningbo Zhejiang, CN
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Baxter Healthcare Corporation
ROUND LAKE, IL, US
Sterigenics Us Llc
Gurnee, IL, US
Ningbo Chinmed Technology Co.,ltd
ningbo Zhejiang, CN
Hubei V-medical Products Co., Ltd.
Xiantao Hubei, CN
Stryker Instruments
Portage, MI, US
Ivt Medical Ltd.
Raanana Central, IL
Xinhua Surgical Instrument Co. Ltd.
ZIBO Shandong, CN
Dfix
GIMPO Gyeonggi, KR
Sonele Inc.
Markham Ontario, CA
Hi-tech Products De Mexico S.a. De C.v.
La Mesa, Tijuana Baja California, MX
Nanjing J Sun Healthcare Co.,ltd
Nanjing Jiangsu, CN
Isomedix Operations, Inc.
Libertyville, IL, US
Andersen Scientific, Inc.
Morrisville, NC, US
Zhejiang Ailebao Medical Technology Co., Ltd
Wenzhou Zhejiang, CN
Shanghai Joy Crown Industry Co., Ltd
Pu Dong New Area Shanghai, CN
Surginus Co.,ltd.
Daejeon, KR
Zapalign Inc.
Anyang-si Gyeonggi, KR
Steris Applied Sterilization Technologies Ulc
WHITBY Ontario, CA
Weihai Kangzheng Medical Equipments Technology Co.,ltd
weihai Shandong, CN
Suturegard Medical, Inc.
Corvallis, OR, US
Anji Spenq Industrial Co., Ltd.
Huzhou Zhejiang, CN
Pepin Mfg., Inc.
LAKE CITY, MN, US
510(k) clearances
6 clearances for this product code
- Wisebands , Ltd.Mar 15, 2001
K002315 · WISEBANDS SKIN CLOSURE DEVICE
- Progressive Surgical Products, Inc.Sep 8, 1998
K982439 · PROXIDERM, MODELS TN 460, TN 90 460, BK 460
- Progressive Surgical Products, Inc.Apr 16, 1997
K970439 · PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
- Phoenix Biomedical Corp.Jan 14, 1997
K962144 · PHOENIX ETE TISSUE EXTENSION SYSTEM
- Progressive Surgical Products, Inc.Nov 4, 1994
K942425 · PROXIDERM (TENTATIVE)
- Life Medical Sciences, Inc.Jul 19, 1994
K942526 · SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM