Ring (wound Protector), Drape Retention, Internal
General, Plastic Surgery · 21 CFR 878.4370
Recent MDR events
183 adverse event reports on file
- ALEXIS LAPAROSCOPIC SYSTEMApr 29, 2026MalfunctionApplied Medical Resources2027111-2026-00527
- ALEXIS LAPAROSCOPIC SYSTEMMar 5, 2026MalfunctionApplied Medical Resources2027111-2026-00414
- ALEXIS WOUND PROTECTOR-RETRACTORFeb 27, 2026MalfunctionApplied Medical Resources2027111-2026-00402
- ALEXIS O WOUND PROTECTOR-RETRACTORFeb 12, 2026MalfunctionApplied Medical Resources2027111-2026-00363
- ALEXIS O WOUND PROTECTOR-RETRACTORFeb 12, 2026MalfunctionApplied Medical Resources2027111-2026-00364
- ALEXIS WOUND PROTECTOR-RETRACTORFeb 12, 2026MalfunctionApplied Medical Resources2027111-2026-00366
- ALEXIS WOUND PROTECTOR-RETRACTORFeb 11, 2026MalfunctionApplied Medical Resources2027111-2026-00357
- ALEXIS LAPAROSCOPIC SYSTEMNov 20, 2025MalfunctionApplied Medical Resources2027111-2025-00877
- ALEXIS WOUND PROTECTOR-RETRACTORNov 18, 2025MalfunctionApplied Medical Resources2027111-2025-00866
- ALEXIS O WOUND PROTECTOR-RETRACTOROct 9, 2025MalfunctionApplied Medical Resources2027111-2025-00796
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
38 firms currently registered for this product code
Schneider Asr B.v.
Rotterdam-Albrandswaard Zuid-Holland, NL
Cardinal Health
Hazelwood, MO, US
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
Cardinal Health 200, Llc
Waukegan, IL, US
Applied Medical Distribution Center
Irvine, CA, US
Sterigenics U.s., Llc
Charlotte, NC, US
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.
Cuauhtemoc Chihuahua, MX
Sterigenics Us Llc
Grand Prairie, TX, US
Jiangsu Haize Medical Scientific Development Co.,ltd.
Wuxi Jiangsu, CN
Guangzhou T.k Medical Instrument Co., Ltd.
Guangzhou Guangdong, CN
Sterigenics U.s., Llc
Santa Teresa, NM, US
Stymco Medical Llc
Tampa, FL, US
Solventum Us Llc
Brookings, SD, US
Vlv Associates, Inc.
Whippany, NJ, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Applied Medical Resources Corp.
RSM, CA, US
Unimax Medical Systems Inc.
New Taipei City, TW
Isomedix Operations Inc.
WHIPPANY, NJ, US
Hakko Co., Ltd.
CHIKUMA-SHI Nagano, JP
Jiangsu Medplus Non-woven Manufacturer Co.,ltd.
Siyang Jiangsu, CN
510(k) clearances
9 clearances for this product code
- Applied Medical Resources CorporationApr 24, 2026
K260982 · Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)
- Applied Medical Resources CorporationFeb 23, 2026
K253531 · Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
- Applied Medical Resources Corp.Feb 8, 2013
K113268 · ALEXIS O WOUND PROTECTOR/RETRACTOR
- Applied Medical Resources Corp.Apr 2, 2010
K100120 · ALEXIS ORTHOPAEDIC WOUND RETRACTOR
- Applied Medical Resources Corp.Nov 5, 2009
K093296 · ALEXIS LAPAROSCOPIC SYSTEM
- Applied Medical ResourcesJan 9, 2007
K062907 · ALEXIS WOUND RETRACTOR
- Applied Medical Resources Corp.Aug 26, 2004
K041711 · ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
- Gainor MedicalAug 17, 1984
K840946 · MICROPOROUS HYPOALLERGENIC