Schoelly Fiberoptic GmbH is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Schoelly Fiberoptic GmbH - FDA 510(k) Cleared Devices
Recent clearances: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source, TipVision Videoscope System (TipVision VideoScope 0°/30°
12
Total
12
Cleared
0
Denied
Schoelly Fiberoptic GmbH has 12 FDA 510(k) cleared medical devices. Based in Ayer, US.
Latest FDA clearance: Jun 2024. Active since 1999.
Browse the FDA 510(k) cleared devices submitted by Schoelly Fiberoptic GmbH Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Delphi Medical Device Consulting, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Schoelly Fiberoptic GmbH
12 devices
Cleared
Jun 20, 2024
SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit,...
General & Plastic Surgery
266d
Cleared
Feb 23, 2023
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic...
General & Plastic Surgery
266d
Cleared
Mar 12, 2021
TipVision Videoscope System (TipVision VideoScope 0°/30°
Obstetrics & Gynecology
270d
Cleared
Oct 08, 2020
Schoelly Cystoscopes/Hysteroscopes and Accessories
Obstetrics & Gynecology
85d
Cleared
Feb 09, 2016
Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
Gastroenterology & Urology
267d
Cleared
Mar 09, 2015
Schoelly Cystoscopes/Hysteroscopes and Accessories
Obstetrics & Gynecology
45d
Cleared
Mar 04, 2015
CMOS Video Nasopharyngoscope System
Ear, Nose, Throat
70d
Cleared
Jan 27, 2015
SCHOELLY SINUSCOPE
Ear, Nose, Throat
166d
Cleared
Dec 05, 2014
Schoelly Laparoscope
General & Plastic Surgery
25d
Cleared
Apr 09, 2014
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
Ear, Nose, Throat
282d
Cleared
Aug 05, 1999
FLEXISCOPE IQ 101
Gastroenterology & Urology
21d
Cleared
Mar 29, 1999
FLEXISCOPE OPTOMODUL
Dental
88d