FWGClass I
Camera, Television, Endoscopic, With Audio
General, Plastic Surgery · 21 CFR 878.4160
MDR events5All time
Recalls0All time
Registered firms12Currently listed
510(k) clearances2All time
Recent MDR events
5 adverse event reports on file
- ATMOS SCOPEMar 28, 2022MalfunctionMedizin Technik Gmbh & Co. / Atmos Medizintechnik Gmbh & Co. KgMW5108574
- KARL STORZMar 22, 2008OtherKarl Storz Imaging2020550-2008-00007
- *Mar 22, 2008OtherKarl Storz Imaging, Inc.2027009-2008-00007
- SARITAJul 12, 2005InjuryArjo Med Ab Ltd.9617021-2005-00043
- SARA POWERAug 20, 1999OtherArjo Ltd9617021-1999-00033
Event type breakdown
Other3
Injury1
Malfunction1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
12 firms currently registered for this product code
Mahe Medical Usa
Laramie, WY, US
Thd Spa
Correggio Reggio Emilia, IT
Atmos Inc.
Exton, PA, US
Atmos Medizintechnik Gmbh & Co. Kg
LENZKIRCH Baden-Wurttemberg, DE
Asensus Surgical Israel Ltd.
Yokne'am Illit Northern, IL
Inventis Srl
Padova, IT
Asensus Surgical, Inc.
Morrisville, NC, US
Pentax Of America, Inc.
MONTVALE, NJ, US
Medcare Solutions Gmbh
Emmingen Baden-Wurttemberg, DE
Asensus Surgical, Inc.
Durham, NC, US
Richard Wolf Gmbh
KNITTLINGEN Baden-Wurttemberg, DE
510(k) clearances
2 clearances for this product code