Home › Device types › EPT
Microscope, Surgical
FDA product code EPT · Class 1 · General, Plastic Surgery
690
Registered devices
474
Adverse events
14
Recalls
18
510(k) clearances
Devices with this code
CAMERA COUPLER FOR CANON POWERSHOT POINT-AND-SHOOT CAMERAS, FLANGE-MOUNT TO CANO — GLOBAL SURGICAL CORPORATIONMICROSCOPE — EclerisOBJECTIVE LENS, F=225MM, FIXED — GLOBAL SURGICAL CORPORATIONJEDMED — JEDMED INSTRUMENT COMPANYSEILER MEDICAL DIVISION — SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDSEILER MEDICAL DIVIVSION — SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDSEILER MEDICAL DIVISION — SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDSILICONE EYECUP, 5/8" TALL, FOR A & G-SERIES EYEPIECES — GLOBAL SURGICAL CORPORATION300MM OBJECTIVE LENS, 20MM FINE FOCUS ADJUSTMENT, A-SERIES — GLOBAL SURGICAL CORPORATIONModus V — Synaptive Medical IncJEDMED — JEDMED INSTRUMENT COMPANYJEDMED — JEDMED INSTRUMENT COMPANYInfrared imaging unit — OLYMPUS MEDICAL SYSTEMS CORP.PROvido — Leica Microsystems (Schweiz) AGMICROSCOPE — EclerisDUAL IRIS DIAPHRAGM, G-SERIES — GLOBAL SURGICAL CORPORATIONJEDMED — JEDMED INSTRUMENT COMPANYM320 Optics Carrier — Leica Microsystems (Schweiz) AGSINGLE PORT BEAMSPLITTER, 95/5 (VIRTUAL) PORT, A-SERIES — GLOBAL SURGICAL CORPORATIONJEDMED — JEDMED INSTRUMENT COMPANYJEDMED — JEDMED INSTRUMENT COMPANYJEDMED — JEDMED INSTRUMENT COMPANYMICROSCOPE — EclerisFIBEROPTIC CABLE, SS WITH VINYL SHEATH, 6MM X 141" — GLOBAL SURGICAL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-21 | Leica Microsystems, Inc. | There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the over |
| 2022-11-21 | Leica Microsystems, Inc. | There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the over |
| 2020-05-20 | Leica Microsystems, Inc. | Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage. |
| 2019-07-31 | Haag-Streit USA Inc | software error in the central control unit of the floor stand. |
| 2019-07-31 | Haag-Streit USA Inc | software error in the central control unit of the floor stand. |
| 2019-07-31 | Haag-Streit USA Inc | software error in the central control unit of the floor stand. |
| 2018-09-04 | Leica Microsystems, Inc. | The firm received complaints that the instrument tipped over when the swing arm was fully extended. |
| 2018-06-04 | Leica Microsystems, Inc. | Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the pa |
| 2017-01-01 | Seiler Instr. & Mfg. Co. Inc. | The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post. |
| 2013-04-18 | Carl Zeiss Meditec, Inc. | Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope instal |
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