Olympus Surgical Technologies America is one of 16108 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Olympus Surgical Technologies America - FDA 510(k) Cleared Devices
Recent clearances: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories), SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories), SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
14
Total
14
Cleared
0
Denied
Olympus Surgical Technologies America has 14 FDA 510(k) cleared medical devices. Based in Southborough, US.
Latest FDA clearance: Sep 2026. Active since 2012. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Olympus Surgical Technologies America Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Olympus Surgical Technologies America
14 devices
Cleared
Sep 16, 2026
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
Gastroenterology & Urology
30d
Cleared
Jul 24, 2026
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
Gastroenterology & Urology
101d
Cleared
Aug 23, 2024
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
Gastroenterology & Urology
29d
Cleared
Sep 27, 2021
POWERSEAL Curved Jaw Sealer and Divider, Double Action
General & Plastic Surgery
38d
Cleared
Mar 18, 2020
ViziShot 2 FLEX
Anesthesiology
90d
Cleared
Aug 09, 2019
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
General & Plastic Surgery
226d
Cleared
Apr 04, 2019
CleverLock Guidewire Locking Device and Biopsy Cap
Gastroenterology & Urology
63d
Cleared
Jul 03, 2018
PeriView FLEX
Ear, Nose, Throat
60d
Cleared
Sep 21, 2017
PeriView FLEX
Ear, Nose, Throat
147d
Cleared
Apr 06, 2017
ViziShot 2 FLEX
Ear, Nose, Throat
115d
Cleared
Mar 27, 2015
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
Gastroenterology & Urology
98d
Cleared
Oct 21, 2013
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
Gastroenterology & Urology
98d
Cleared
Feb 04, 2013
VARI-PASS VARIABLE LENGTH ACCESS SHEATH
Gastroenterology & Urology
118d
Cleared
Dec 14, 2012
GYRUS ACMI BICOAG HEMOSTASIS PROBE
Gastroenterology & Urology
49d