Olympus America, Inc.
Olympus America, Inc. holds FDA 510(k) medical device clearances, first cleared 1994, most recent 2012, with 4 FDA device recalls on record.
Top product codes for Olympus America, Inc.
FDA recalls by Olympus America, Inc.
- Z-2807-2015 — EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
- Z-0432-2014 — TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
- Z-0329-2014 — Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
- Z-1277-2013 — Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Olympus America, Inc.
1–100 of 149- K111788 — ENDOEYE HD II
- K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
- K073487 — OLYMPUS IGM REAGENT
- K073489 — OLYMPUS IGA REAGENT
- K073490 — OLYMPUS IGG REAGENT
- K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
- K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM
- K061499 — OSFERION
- K062581 — OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
- K061575 — OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
- K060201 — OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
- K051564 — OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
- K051541 — GF-UE160-AL5 ULTRASOUND ENDOSCOPE
- K043460 — OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
- K043202 — OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
- K042406 — OLYMPUS LACTATE, OSR6193
- K041668 — OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
- K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
- K040692 — OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023
- K040471 — OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024
- K032665 — OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
- K031380 — OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
- K032285 — OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
- K030045 — OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
- K030124 — OLYMPUS FERRITIN REAGENT
- K021074 — VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
- K021073 — VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
- K014015 — OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
- K014032 — OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
- K013066 — HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
- K011886 — OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
- K011720 — OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
- K001744 — OLYMPUS ENDOSCOPIC LIGATION DEVICE
- K003721 — MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
- K002918 — OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
- K002982 — OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
- K994103 — OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT
- K994069 — OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE
- K994106 — OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE
- K991672 — OLYMPUS NA-10J-KB ASPIRATION NEEDLE
- K984358 — OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
- K992086 — OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
- K990237 — TROCAR SYSTEM ACCORDING TO HASSON
- K991136 — B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
- K984417 — BIPOLAR GRASPING FORCEPS BIQ+
- K982323 — OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE
- K982725 — OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
- K982289 — HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
- K981743 — OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
- K981305 — OLYMPUS SERUM PROTEIN MULTICALIBRATOR
- K980465 — OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
- K973128 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE
- K964661 — HX-20/21-1 ENDOSCOPIC LIGATOR
- K971660 — OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
- K971416 — OLYMPUS OES OTV-S5C VIDEO SYSTEM
- K971328 — OLYMPUS CD-6C-1 COAGULATION ELECTRODE
- K963160 — HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
- K971817 — OLYMPUS CK-MB REAGENT
- K970797 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES
- K960068 — SH-1 SURGICAL HOLDER FOR TELESCOPE
- K970184 — OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
- K970563 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE
- K954488 — ROLLER ELECTRODE
- K963640 — OLYMPUS ACID PHOSPHATASE REAGENT
- K963023 — ULTRASOUND GASTROSCOPE GF TYPE UM30P
- K963139 — OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
- K963424 — OLYMPUS LIPASE REAGENT
- K963184 — OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
- K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
- K950719 — OES UROLOGY
- K963170 — OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
- K962925 — OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
- K962409 — OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
- K962582 — OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
- K961048 — OLYMPUS MH-246R BALLOON SHEATH
- K963033 — BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
- K961860 — A4907 LENS CLEANING SHEATH
- K962485 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)
- K962901 — OLYMPUS B5-2C/B7-2C BALLOON CATHETER
- K962380 — OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)
- K962533 — OLYPUS FG SERIES GRASPING FORCEPS
- K962367 — OLYMPUS BASKET GRASPERS
- K962378 — OLYMPUS FG-45/46-1 GRASPING FORCEPS
- K962387 — OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
- K962555 — OLYMPUS FB SERIES BIOPSY FORCEPS
- K961611 — OLYMPUS BASKET GRASPERS (UROLOGY)
- K961274 — OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
- K955247 — OLYMPUS KD SERIES SPHINCTEROTOME
- K951994 — OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER
- K954451 — EVIS 140 SYSTEM
- K955650 — OLYMPUS SD SERIES SNARES
- K955403 — OES LAPARO-THORACO VIDEOSCOPE TYPE V
- K955456 — OES LAPARO-THORACO VIDEOSCOPE (RIGID)
- K954537 — OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
- K955623 — OLYMPUS BIPOLAR FORCEPS
- K952892 — OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
- K955139 — OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT
- K955404 — OTV-S5 OES VIDEO SYSTEM
- K955752 — OLYMPUS URIC ACID REAGENT
- K955066 — OLYMPUS FG SERIES GRASPING FORCEPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.