Topical Approximation System
General Hospital · 21 CFR 880.5240
Recent MDR events
89 adverse event reports on file
- LEUKOSTRIP 13X102MM CTN 50Apr 23, 2022MalfunctionSmith & Nephew Medical Ltd.8043484-2022-00125
- LEUKOSTRIP 13X102MM CTN 50Apr 5, 2022MalfunctionSmith & Nephew Medical Ltd.8043484-2022-00120
- LEUKOSTRIP 13X102MM CTN 50Mar 16, 2022MalfunctionSmith & Nephew Medical Ltd.8043484-2022-00102
- LEUKOSTRIP ASS 38X4MM 76X6.4MM CTN 20Apr 28, 2021MalfunctionSmith & Nephew Medical Ltd.8043484-2021-00985
- LEUKOSTRIP 6.4X102MM CTN 50Nov 4, 2020InjurySmith & Nephew Medical Ltd.8043484-2020-03739
- LEUKOSTRIP 13X102MM CTN 50Nov 4, 2020InjurySmith & Nephew Medical Ltd.8043484-2020-03740
- LEUKOCLIP SD CARTRIDGE 10W CTN 10Oct 15, 2020MalfunctionSmith & Nephew Medical Ltd.8043484-2020-03219
- LEUKOCLIP SD HANDLEAug 19, 2020MalfunctionSmith & Nephew Medical Ltd.8043484-2020-02533
- LEUKOCLIP SD HANDLEAug 19, 2020MalfunctionSmith & Nephew Medical Ltd.8043484-2020-02534
- LEUKOCLIP SD HANDLEAug 16, 2020MalfunctionSmith & Nephew Medical Ltd.8043484-2020-02520
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
15 firms currently registered for this product code
Packaging Compliance Medical, Llc
Kentwood, MI, US
Isomedix Operations, Inc.
Libertyville, IL, US
Shanghai Iso Medical Products Co., Ltd.
SHANGHAI, CN
Atc Technologies Inc.
Wilmington, MA, US
Smith & Nephew Medical Ltd
HULL East Riding of Yorkshire, GB
Pepin Mfg., Inc.
LAKE CITY, MN, US
Clozex Medical, Inc.
Franklin, MA, US
Rece International Corp.
Miami, FL, US
Cleftalign Inc.
New York, NY, US
Fortune Medical Instrument Corp.
Taoyuan City, TW
Cordica Medical, Inc. (formally Team Technologies, Inc.)
Chino, CA, US
Steris Applied Sterilization Technologies Ulc
WHITBY Ontario, CA
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Southmedic, Inc.
BARRIE Ontario, CA
Shanghai Neo-medical Import & Export Co., Ltd.
SHANGHAI, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.