Camera, Television, Endoscopic, Without Audio
General, Plastic Surgery · 21 CFR 878.4160
Recent MDR events
288 adverse event reports on file
- CAMERA HEAD AC - C-MOUNTJul 27, 2026MalfunctionMedos International Sã rl1221934-2026-03294
- CAMERA HEAD AC - C-MOUNTJul 16, 2026MalfunctionMedos International Sã rl1221934-2026-03131
- CAMERA HEAD AC - C-MOUNTJul 15, 2026MalfunctionMedos International Sã rl1221934-2026-03103
- CAMERA HEAD AC - C-MOUNTJul 15, 2026MalfunctionMedos International Sarl1221934-2026-03116
- CAMERA HEAD AC C MOUNT CHINA LOCALJul 10, 2026MalfunctionMedos International Sã rl1221934-2026-03001
- CAMERA HEAD AC - C-MOUNTJul 1, 2026MalfunctionMedos International Sã rl1221934-2026-02866
- CAMERA HEAD AC - C-MOUNTJul 1, 2026MalfunctionMedos International Sã rl1221934-2026-02868
- CAMERA HEAD AC - C-MOUNTJun 29, 2026MalfunctionMedos International Sã rl1221934-2026-02831
- CAMERA HEAD AC - C-MOUNTJun 15, 2026MalfunctionMedos International Sã rl1221934-2026-02581
- CAMERA HEAD AC C MOUNT CHINA LOCALJun 3, 2026MalfunctionMedos International Sã rl1221934-2026-02377
Event type breakdown
Recalls
2 recall events for this product code
- Smith & Nephew, Inc Endoscopy DivisionTerminatedMay 5, 2007
SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
Z-0781-2007 · View FDA record ↗ - Smith & Nephew, Inc Endoscopy DivisionTerminatedMay 5, 2007
SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
Z-0782-2007 · View FDA record ↗
Registered firms
67 firms currently registered for this product code
Ecleris Srl
Villa Martelli Buenos Aires, AR
Sopro
LA CIOTAT CEDEX Bouches-du-Rhone, FR
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Hayden Medical Inc
Valencia, CA, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Tonglu Wanhe Medical Instrument Co., Ltd.
Hangzhou Zhejiang, CN
Healthium Medtech Limited
BANGALORE Karnataka, IN
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Hunan Endoso Life Technology Co., Ltd
XiangTan Hunan, CN
Joimax Gmbh
KARLSRUHE Baden-Wurttemberg, DE
Mediana Co., Ltd.
Wonju-Si, Gangwon-do, KR
Anhui Shiyin Photoelectric Instrument Co., Ltd.
Suzhou Anhui, CN
Novaprobe Inc.
Lansdale, PA, US
National Advanced Endoscopy Devices, Inc.
CANOGA PARK, CA, US
Karl Storz Imaging, Inc.
Goleta, CA, US
Smith & Nephew Inc.
OKLAHOMA CITY, OK, US
Schoelly-optix Ood
Panagyurishte Pazardzhik, BG
Jmu Dental, Inc
Fullerton, CA, US
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
510(k) clearances
23 clearances for this product code
- Schoelly Imaging, Inc.Feb 23, 2006
K053412 · FLEXISCOPE, MODELS 50MH AND 50 MHC
- Karl Storz Imaging, Inc.Jun 1, 1999
K990154 · KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
- A.Stein - Regulatory Affairs ConsultingJan 8, 1999
K982754 · EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
- Richard Wolf Medical Instruments Corp.Nov 23, 1998
K982965 · ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
- Angiolaz, Inc.Sep 10, 1998
K982397 · VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
- Angiolaz, Inc.Aug 21, 1998
K982409 · VES 1501-M
- Angiolaz, Inc.Aug 4, 1998
K981819 · ANGIOLAZ VES-1CAM
- Envision Medical Corp.Oct 7, 1994
K944707 · ISOLATED CAMERA HEAD