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Microscope, Surgical

FDA product code EPT · Class 1 · General, Plastic Surgery

688
Registered devices
473
Adverse events
14
Recalls
18
510(k) clearances

Devices with this code

JEDMED — JEDMED INSTRUMENT COMPANYRING FLASH ADAPTER FOR M A1028-XXX A-SERIES OBJECTIVES, WITH M 62 X 0.75 FEMALE — GLOBAL SURGICAL CORPORATIONG-SERIES 4-STEP MICROSCOPE WITH 120 DEGREE ANGLED COUNTERBALANCE COUPLER, LED RE — GLOBAL SURGICAL CORPORATIONG-SERIES COUNTERBALANCE 120 DEGREE ANGLED COUPLER ARM UPGRADE KIT, WHITE — GLOBAL SURGICAL CORPORATIONCaptiView — Leica Microsystems (Schweiz) AGA-SERIES 3 STEP MICROSCOPE WITH AXIS SYSTEM AND COUPLER — GLOBAL SURGICAL CORPORATIONJEDMED — JEDMED INSTRUMENT COMPANYMitaka 3D Viewer — MITAKA KOHKI CO., LTD.VITOM — Karl Storz GmbH & Co. KGJEDMED — JEDMED INSTRUMENT COMPANYSurgical Microscope MM80/SS1 — MITAKA KOHKI CO., LTD.FL400 — Leica Microsystems (Schweiz) AGMICROSCOPE — EclerisA-SERIES CASES (2) WITH FOAM LINERS FOR TABLETOP MICROSCOPE OPTICS AND V-BASE — GLOBAL SURGICAL CORPORATIONG-SERIES CARR BINOCULAR EXTENDER, WHITE, 45 DEGREE INCLINATION — GLOBAL SURGICAL CORPORATIONLED ILLUMINATION MODULE WITH COMPOSITE FILTER, ENTREE SERIES, INTERNATIONAL — GLOBAL SURGICAL CORPORATIONJEDMED — JEDMED INSTRUMENT COMPANYG-SERIES 45 DEGREE INCLINED BINOCULAR, WHITE, 10X EYEPIECES, F=160MM — GLOBAL SURGICAL CORPORATIONMICROSCOPE — EclerisMICROSCOPE — EclerisG-SERIES HIGH WALL MOUNT, SHAFT DOWN, 20" COLUMN ARM, SPRINGARM, INTERNAL CABLE — GLOBAL SURGICAL CORPORATIONG-SERIES 6-STEP MICROSCOPE WITH STRAIGHT COUPLER, WHITE — GLOBAL SURGICAL CORPORATIONG-SERIES 15" ADDITIONAL COLUMN ARM, SHAFTS ON SAME SIDE, INTERNAL CABLE CHANNEL, — GLOBAL SURGICAL CORPORATIONFIXED 45 DEGREE INCLINED BINOCULAR, A-SERIES, 10X EYEPIECES, F:160, RETICLE IN R — GLOBAL SURGICAL CORPORATION

Recent recalls

DateFirmReason
2022-11-21Leica 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
2022-11-21Leica 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
2020-05-20Leica Microsystems, Inc.Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
2019-07-31Haag-Streit USA Incsoftware error in the central control unit of the floor stand.
2019-07-31Haag-Streit USA Incsoftware error in the central control unit of the floor stand.
2019-07-31Haag-Streit USA Incsoftware error in the central control unit of the floor stand.
2018-09-04Leica Microsystems, Inc.The firm received complaints that the instrument tipped over when the swing arm was fully extended.
2018-06-04Leica 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
2017-01-01Seiler 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.
2013-04-18Carl 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.