| 18 Aug 2026 | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories | Device | Class II | 1 | Ongoing |
| 7 Jul 2026 | Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color. | Device | Class II | 1 | Ongoing |
| 16 Jun 2026 | Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 | Device | Class II | 1 | Ongoing |
| 5 Jun 2026 | Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid | Device | Class II | 1 | Ongoing |
| 5 May 2026 | Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. | Device | Class II | 4 | Ongoing |
| 25 Mar 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE. | Device | Class II | 12 | Ongoing |
| 23 Mar 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. | Device | Class II | 4 | Ongoing |
| 27 Feb 2026 | Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis,… | Device | Class II | 2 | Ongoing |
| 25 Feb 2026 | Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under… | Device | Class II | 7 | Ongoing |
| 12 Feb 2026 | Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. | Device | Class II | 4 | Ongoing |
| 29 Jan 2026 | Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids. | Device | Class II | 2 | Ongoing |
| 16 Jan 2026 | Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. | Device | Class I | 3 | Ongoing |
| 8 Jan 2026 | Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic… | Device | Class II | 1 | Ongoing |
| 7 Jan 2026 | Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. | Device | Class II | 30 | Ongoing |
| 14 Nov 2025 | Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer… | Device | Class II | 3 | Ongoing |
| 11 Nov 2025 | Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications. | Device | Class II | 20 | Ongoing |
| 30 Oct 2025 | Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare. | Device | Class I | 1 | Ongoing |
| 22 Oct 2025 | Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S | Device | Class II | 12 | Ongoing |
| 17 Oct 2025 | Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a… | Device | Class II | 1 | Ongoing |
| 14 Oct 2025 | Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other… | Device | Class II | 1 | Ongoing |
| 8 Oct 2025 | Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that… | Device | Class II | 1 | Ongoing |
| 6 Oct 2025 | Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps,… | Device | Class II | 2 | Ongoing |
| 11 Sep 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 | Device | Class I | 23 | Ongoing |
| 6 Aug 2025 | ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube. | Device | Class I | 1 | Ongoing |
| 25 Jul 2025 | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments… | Device | Class II | 2 | Ongoing |
| 18 Jun 2025 | Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures. | Device | Class II | 8 | Ongoing |
| 6 May 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue… | Device | Class II | 4 | Ongoing |
| 5 May 2025 | Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V | Device | Class II | 1 | Ongoing |
| 4 Apr 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component:… | Device | Class II | 1 | Ongoing |
| 15 Jan 2025 | Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number:… | Device | Class I | 1 | Ongoing |
| 18 Dec 2024 | Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories. | Device | Class I | 1 | Ongoing |
| 16 Dec 2024 | LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct. | Device | Class II | 1 | Ongoing |
| 25 Nov 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended… | Device | Class II | 11 | Ongoing |
| 19 Nov 2024 | Duravent Silicone Ventilation Tube. Model Number: 240075. | Device | Class II | 1 | Ongoing |
| 31 Oct 2024 | EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 | Device | Class II | 1 | Ongoing |
| 24 Sep 2024 | Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in… | Device | Class II | 1 | Ongoing |
| 18 Sep 2024 | Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy… | Device | Class II | 1 | Ongoing |
| 13 Sep 2024 | EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055 | Device | Class II | 1 | Ongoing |
| 13 Sep 2024 | Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A | Device | Class II | 1 | Ongoing |
| 13 Sep 2024 | Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; | Device | Class II | 1 | Ongoing |
| 11 Sep 2024 | Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Olympus UroPass Ureteral… | Device | Class II | 1 | Ongoing |
| 4 Sep 2024 | Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U | Device | Class II | 1 | Ongoing |
| 23 Aug 2024 | Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) | Device | Class II | 1 | Ongoing |
| 21 Aug 2024 | Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 | Device | Class II | 1 | Ongoing |
| 13 Aug 2024 | Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS | Device | Class II | 2 | Ongoing |
| 1 Jul 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws… | Device | Class II | 3 | Ongoing |
| 21 Jun 2024 | ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C | Device | Class II | 1 | Ongoing |
| 31 May 2024 | Soltive Premium SuperPulsed Laser System, Model TFL-PLS | Device | Class II | 3 | Ongoing |
| 24 Apr 2024 | EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and… | Device | Class II | 1 | Ongoing |
| 18 Apr 2024 | OES 4000 Hysteroscope, Model/Catalog Number: A4674A | Device | Class II | 1 | Ongoing |
| 3 Apr 2024 | InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity. | Device | Class II | 1 | Ongoing |
| 7 Mar 2024 | POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA | Device | Class II | 3 | Ongoing |
| 1 Mar 2024 | Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L | Device | Class II | 2 | Ongoing |
| 17 Feb 2024 | Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a… | Device | Class II | 2 | Ongoing |
| 29 Jan 2024 | SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) | Device | Class II | 2 | Ongoing |
| 16 Jan 2024 | InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K45BTOL LCS1545TPOL LCS1845TPST LCS4K45TPOL… | Device | Class II | 1 | Ongoing |
| 16 Jan 2024 | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI. | Device | Class II | 1 | Ongoing |
| 11 Jan 2024 | Colonoscope, Model Number CF-H180AL. | Device | Class II | 10 | Ongoing |
| 5 Jan 2024 | Hemostasis Probe, Model: CD-B622LA | Device | Class II | 1 | Ongoing |
| 15 Dec 2023 | ESG PK CUTTING FORCEPS, 5MM, 33CM | Device | Class II | 1 | Ongoing |
| 11 Dec 2023 | Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044 | Device | Class II | 1 | Ongoing |
| 8 Dec 2023 | Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator | Device | Class II | 1 | Ongoing |
| 4 Dec 2023 | SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS | Device | Class II | 1 | Ongoing |
| 4 Dec 2023 | Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940 | Device | Class II | 2 | Ongoing |
| 1 Dec 2023 | SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS | Device | Class II | 1 | Ongoing |
| 20 Nov 2023 | OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities,… | Device | Class II | 2 | Ongoing |
| 10 Nov 2023 | EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880 | Device | Class II | 12 | Ongoing |
| 6 Nov 2023 | Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including… | Device | Class II | 1 | Ongoing |
| 12 Oct 2023 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160 | Device | Class I | 6 | Ongoing |
| 2 Oct 2023 | ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar… | Device | Class II | 1 | Ongoing |
| 2 Oct 2023 | EVIS EXERA III Gastrointestinal Videoscope | Device | Class II | 1 | Ongoing |
| 28 Sep 2023 | TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP | Device | Class II | 1 | Ongoing |
| 25 Sep 2023 | Insufflation unit, UHI-4. | Device | Class II | 1 | Ongoing |
| 22 Sep 2023 | Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. | Device | Class I | 1 | Ongoing |
| 14 Sep 2023 | EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation | Device | Class II | 1 | Ongoing |
| 12 Sep 2023 | THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis,… | Device | Class II | 2 | Ongoing |
| 10 Aug 2023 | Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-2400 SPiN Drive System SYS-2230 ig4 System V2, 230V, 50Hz… | Device | Class II | 6 | Ongoing |
| 27 Jul 2023 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V | Device | Class II | 1 | Ongoing |
| 27 Jul 2023 | Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160. | Device | Class II | 15 | Ongoing |
| 20 Jul 2023 | Visera Hysterovideoscope Olympus HYF Type V | Device | Class II | 1 | Ongoing |
| 12 Jul 2023 | The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5 | Device | Class II | 1 | Ongoing |
| 8 Jun 2023 | Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60 | Device | Class I | 7 | Ongoing |
| 8 Jun 2023 | HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A22207C 9) A22211C 10) A22221C 11) A22222C 12) A22223C 13)… | Device | Class II | 1 | Ongoing |
| 26 May 2023 | VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management. | Device | Class II | 5 | Ongoing |
| 19 May 2023 | UroPass Ureteral Access Sheaths, 5 pieces/box | Device | Class II | 1 | Ongoing |
| 15 May 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352 | Device | Class II | 8 | Ongoing |
| 4 May 2023 | Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A | Device | Class II | 4 | Ongoing |
| 18 Apr 2023 | Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100 | Device | Class II | 1 | Ongoing |
| 31 Mar 2023 | ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A | Device | Class III | 2 | Ongoing |
| 23 Feb 2023 | Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip | Device | Class II | 1 | Ongoing |
| 21 Dec 2022 | EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL | Device | Class II | 1 | Ongoing |
| 13 Dec 2022 | SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) | Device | Class II | 1 | Ongoing |
| 4 Nov 2022 | HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S | Device | Class II | 1 | Ongoing |
| 16 Sep 2022 | Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity. | Device | Class II | 1 | Ongoing |
| 12 Aug 2022 | Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures. | Device | Class II | 3 | Ongoing |
| 7 Jul 2022 | ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S | Device | Class II | 1 | Ongoing |
| 26 May 2022 | SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use… | Device | Class II | 1 | Terminated |
| 22 Apr 2022 | Colonovideoscope Model CF-H180AL | Device | Class II | 1 | Terminated |
| 22 Apr 2022 | EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190 | Device | Class II | 1 | Ongoing |
| 20 Apr 2022 | Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 | Device | Class II | 3 | Ongoing |
| 31 Mar 2022 | Olympus DISPOSABLE GRASPING FORCEPS, FG-51D | Device | Class II | 1 | Terminated |
| 25 Mar 2022 | Olympus Uretero-reno videoscope, Model No. URF-V2 | Device | Class II | 1 | Ongoing |
| 18 Mar 2022 | Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging. | Device | Class II | 1 | Ongoing |
| 8 Mar 2022 | BF-MP60: OES Bronchofiberscope | Device | Class II | 4 | Ongoing |
| 23 Dec 2021 | Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00 | Device | Class II | 1 | Ongoing |
| 13 Dec 2021 | OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories | Device | Class II | 1 | Terminated |
| 2 Nov 2021 | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V | Device | Class II | 1 | Ongoing |
| 21 Sep 2021 | ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during… | Device | Class II | 1 | Terminated |
| 17 Aug 2021 | EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 | Device | Class II | 1 | Terminated |
| 16 Aug 2021 | BF-N20 OES Bronchofiberscope, Model No. BF-N20 | Device | Class II | 10 | Terminated |
| 3 Aug 2021 | Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to… | Device | Class II | 1 | Terminated |
| 30 Jun 2021 | Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery | Device | Class II | 1 | Terminated |
| 9 Jun 2021 | Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC | Device | Class II | 1 | Terminated |
| 28 Jan 2021 | Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. | Device | Class II | 1 | Terminated |
| 16 Oct 2020 | Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract. | Device | Class II | 10 | Terminated |
| 31 Aug 2020 | Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary… | Device | Class II | 1 | Terminated |
| 31 Aug 2020 | Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct). | Device | Class II | 1 | Terminated |
| 14 Jul 2020 | Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168 | Device | Class II | 2 | Terminated |
| 5 May 2020 | ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen. | Device | Class II | 1 | Terminated |
| 23 Apr 2020 | OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer | Device | Class II | 1 | Terminated |
| 23 Mar 2020 | Olympus Pleuravideoscope, Model LTF-160 | Device | Class II | 2 | Terminated |
| 12 Sep 2019 | Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack | Device | Class II | 1 | Ongoing |
| 10 Jun 2019 | Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664 | Device | Class II | 1 | Terminated |
| 1 Apr 2019 | Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes,… | Device | Class II | 1 | Terminated |
| 17 Dec 2018 | Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. | Device | Class II | 4 | Terminated |
| 8 Aug 2018 | Bronchovideoscope BF-160 | Device | Class II | 30 | Terminated |
| 11 May 2018 | Olympus JF-140F duodenoscopes (Model NumberJF-140F) | Device | Class II | 2 | Terminated |
| 17 Jan 2018 | Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R | Device | Class II | 1 | Terminated |
| 17 Jan 2018 | Uretero-reno fiberscope URF-P6 | Device | Class II | 2 | Terminated |
| 18 Aug 2017 | A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and… | Device | Class II | 1 | Terminated |
| 19 Apr 2017 | High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications. | Device | Class II | 1 | Terminated |
| 10 Feb 2017 | Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603 | Device | Class II | 1 | Terminated |
| 12 Dec 2016 | URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope | Device | Class II | 1 | Terminated |
| 12 Dec 2016 | Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney. | Device | Class II | 1 | Terminated |
| 3 Nov 2016 | HF Cable WA00014A, Endoscopic electrosurgical unit and accessories | Device | Class II | 1 | Terminated |
| 23 Jun 2016 | OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector | Device | Class II | 1 | Terminated |
| 15 Mar 2016 | EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. | Device | Class II | 1 | Terminated |
| 8 Jan 2016 | Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. | Device | Class II | 1 | Terminated |
| 17 Nov 2015 | Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal… | Device | Class II | 1 | Terminated |
| 11 Sep 2015 | MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing. | Device | Class II | 1 | Terminated |
| 21 Aug 2015 | EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs. | Device | Class II | 1 | Terminated |