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Olympus Medical Systems Corporation FDA Approvals
0 new drug approvals and 36 device clearances on file. Matched by name to OLYMY.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)510(k)Aug 27, 2026Radiology |
| Gastrointestinal Videoscope Olympus GIF-2T1500510(k)Aug 27, 2026Gastroenterology, Urology |
| Disposable Distal Attachment D-201-13404510(k)Aug 27, 2026Gastroenterology, Urology |
| EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)510(k)Jul 31, 2026Gastroenterology, Urology |
| HD Camera Head OLYMPUS CH-S200-08-LB510(k)Jun 24, 2026Gastroenterology, Urology |
| Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D510(k)Mar 20, 2026Ear, Nose, Throat |
| Single Use Cytology Brush V (BC-V600P-3010)510(k)Dec 18, 2025Gastroenterology, Urology |
| Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)510(k)Nov 25, 2025Gastroenterology, Urology |
| Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)510(k)Oct 21, 2025Gastroenterology, Urology |
| Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)510(k)Oct 16, 2025Gastroenterology, Urology |
| Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)510(k)Oct 10, 2025Gastroenterology, Urology |
| Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)510(k)Oct 7, 2025General, Plastic Surgery |
| Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)510(k)Oct 7, 2025Gastroenterology, Urology |
| EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)510(k)Oct 3, 2025Gastroenterology, Urology |
| AUXILIARY WATER TUBE MAJ-855510(k)Sep 26, 2025Gastroenterology, Urology |
| Single-Use Biopsy Valve (MAJ-1555)510(k)Sep 25, 2025Gastroenterology, Urology |
| ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)510(k)Sep 18, 2025Radiology |
| Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)510(k)Jul 29, 2025Ear, Nose, Throat |
| Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)510(k)Jul 16, 2025Gastroenterology, Urology |
| ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)510(k)Jul 11, 2025Radiology |
| Disposable Cytology Brush BC-202D/203D Series510(k)Jun 12, 2025Ear, Nose, Throat |
| Disposable Balloon Catheter B5-2C510(k)Jun 4, 2025Ear, Nose, Throat |
| Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)510(k)May 30, 2025Ear, Nose, Throat |
| Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)510(k)May 15, 2025Gastroenterology, Urology |
| Luer-Split MAJ-2092510(k)Mar 19, 2025Gastroenterology, Urology |
| VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)510(k)Mar 3, 2025Ear, Nose, Throat |
| EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)510(k)Jan 17, 2025Radiology |
| High Flow Insufflation Unit (UHI-4)510(k)Jan 13, 2025Obstetrics/Gynecology |
| Water Container (MAJ-901); Water Container (MAJ-902)510(k)Oct 7, 2024Gastroenterology, Urology |
| VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)510(k)Jul 3, 2024Gastroenterology, Urology |
| EVIS Exera III Gastrointestinal Videoscope GIF-1TH190510(k)Jun 19, 2024Gastroenterology, Urology |
| EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100510(k)Jun 15, 2023Ear, Nose, Throat |
| EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100510(k)Apr 26, 2023Gastroenterology, Urology |
| CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)510(k)Jan 20, 2023Gastroenterology, Urology |
| Visera Hysterovideoscope Olympus HYF Type V510(k)Sep 2, 2022Obstetrics/Gynecology |
| Ultrasonic Bipolar Generator USG-410 with accessories510(k)Aug 4, 2021 |