Instrument, Special Lens, For Endoscope
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
19 adverse event reports on file
- CLOSUREFAST 6FR CATHETERMar 26, 2026MalfunctionCovidien9610849-2026-00078
- CAMERA COUPLER AC HD 5:4Sep 8, 2024MalfunctionSmith & Nephew, Inc.3003604053-2024-00048
- CAMERA COUPLER AC HD 5:4May 24, 2024MalfunctionSmith & Nephew, Inc.3003604053-2024-00020
- COUPLER, ZOOM, HD, C-MOUNTJun 20, 2022MalfunctionArthrex, Inc.1220246-2022-05121
- COUPLER, ZOOM, HD, C-MOUNTJun 20, 2022MalfunctionArthrex, Inc.1220246-2022-05122
- COUPLER 19.5MM 5:4 AUTOCLAVABLE HDDec 22, 2020MalfunctionSmith & Nephew, Inc.3003604053-2020-00174
- COUPLER, ZOOM, HD, C-MOUNTAug 18, 2020MalfunctionArthrex, Inc.1220246-2020-02061
- SERV REPL HD COUPLER 19.5MMAug 14, 2019MalfunctionSmith & Nephew, Inc.3003604053-2019-00091
- COUPLER, HD, 19.5MMAug 14, 2019MalfunctionSmith & Nephew, Inc.3003604053-2019-00092
- SERV REPL HD COUPLER 19.5MMAug 8, 2019MalfunctionSmith & Nephew, Inc.3003604053-2019-00090
Event type breakdown
Recalls
2 recall events for this product code
- MedtronicTerminatedUnknown
Covidien Clearify Visualization System
Product sterility is compromised due to breach of the sterile barrier
Z-0889-2017 · View FDA record ↗ - MedtronicTerminatedUnknown
Best Practices kits containing certain production lots of Clearify Visualization System
Product sterility is compromised due to breach of the sterile barrier
Z-0890-2017 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Ovesco Endoscopy Ag
Tuebingen Baden-Wurttemberg, DE
Novanta Medical Gmbh
LUDWIGSSTADT Bavaria, DE
Biogenomics S.a.c. - Biocells Surgical
Lima, PE
Teleflex Llc (nadc)
Olive Branch, MS, US
Arthrex Manufacturing Inc.
Pendleton, SC, US
Access Optics
Broken Arrow, OK, US
Sterigenics Us Llc
West Memphis, AR, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Arthrex California Technology, Incorporated
Santa Barbara, CA, US
Arthrex, Inc.
Naples, FL, US
Arthrex (shanghai) Co., Ltd.
Shanghai, CN
Smith & Nephew Inc.
OKLAHOMA CITY, OK, US
Teleflex Medical Llc
Morrisville, NC, US
Biocells Discoveries Internacional (biocells)
Quito Pichincha, EC
Crosmed S.a.
Buenos Aires, AR
Isomedix Operations Inc.
Northborough, MA, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Smith & Nephew Inc.
MANSFIELD, MA, US
Arthrex, Inc.
Ave Maria, FL, US
Smith & Nephew Inc.
ANDOVER, MA, US
Novanta Medical Gmbh
BERLIN, DE
Arthrex Distribution Hub Emea B.v.
Venlo Limburg, NL
Eurofins Steripac Gmbh
Calw-Altburg Baden-Wurttemberg, DE
Vietmedical Distribution Joint Stock Company
Hanoi Ha Noi, VN
Arthrex Japan G.k. (shinjuku)
Shinjuku-ku Tokyo, JP
510(k) clearances
2 clearances for this product code