OLYMPUS Corporation of the Americas
Center Valley, PA, US
OLYMPUS Corporation of the Americas appears in FDA device records in Center Valley, PA. FDA records list 150 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 436 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to OLYMPUS Corporation of the Americas carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Olympus America, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 150FDA records hold 150 510(k) clearances for OLYMPUS Corporation of the Americas between 1994 and 2014. The busiest year on record is 1995, with 39. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 6 |
| 1995 | 39 |
| 1996 | 37 |
| 1997 | 16 |
| 1998 | 6 |
| 1999 | 6 |
| 2000 | 6 |
| 2001 | 4 |
| 2002 | 4 |
| 2003 | 5 |
| 2004 | 6 |
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133538 | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE | NWB | Substantially Equivalent | |
| K111788 | ENDOEYE HD II | HET | Substantially Equivalent | |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | DHX | Substantially Equivalent | |
| K073490 | OLYMPUS IGG REAGENT | CFN | Substantially Equivalent | |
| K073489 | OLYMPUS IGA REAGENT | CFN | Substantially Equivalent | |
| K073487 | OLYMPUS IGM REAGENT | CFN | Substantially Equivalent | |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | KNK | Substantially Equivalent | |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | CDT | Substantially Equivalent | |
| K061499 | OSFERION | MQV | Substantially Equivalent | |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | JLW | Substantially Equivalent | |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | CJY | Substantially Equivalent | |
| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | DHR | Substantially Equivalent | |
| K051564 | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH | NQD | Substantially Equivalent | |
| K051541 | GF-UE160-AL5 ULTRASOUND ENDOSCOPE | FDF | Substantially Equivalent | |
| K043460 | OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 | JIX | Substantially Equivalent | |
| K043202 | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 | CGS | Substantially Equivalent | |
| K042406 | OLYMPUS LACTATE, OSR6193 | JIT | Substantially Equivalent | |
| K041668 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | NQD | Substantially Equivalent | |
| K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | JMO | Substantially Equivalent | |
| K040692 | OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 | JIT | Substantially Equivalent | |
| K040471 | OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 | JIT | Substantially Equivalent | |
| K032665 | OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 | JIX | Substantially Equivalent | |
| K031380 | OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) | LCP | Substantially Equivalent | |
| K032285 | OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 | JIT | Substantially Equivalent | |
| K030045 | OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) | DIH | Substantially Equivalent | |
| K030124 | OLYMPUS FERRITIN REAGENT | DBF | Substantially Equivalent | |
| K021074 | VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA | FAJ | Substantially Equivalent | |
| K021073 | VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V | EOB | Substantially Equivalent | |
| K014032 | OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA | LBS | Substantially Equivalent | |
| K014015 | OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA | LBS | Substantially Equivalent | |
| K013066 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | MND | Substantially Equivalent | |
| K011886 | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, | ODG | Substantially Equivalent | |
| K011720 | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER | CIX | Substantially Equivalent | |
| K001744 | OLYMPUS ENDOSCOPIC LIGATION DEVICE | MND | Substantially Equivalent | |
| K003721 | MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | JJE | Substantially Equivalent | |
| K002982 | OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | JJE | Substantially Equivalent | |
| K002918 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | DCN | Substantially Equivalent | |
| K994103 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT | ITX | Substantially Equivalent | |
| K994106 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE | ITX | Substantially Equivalent | |
| K994069 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE | ITX | Substantially Equivalent | |
| K991672 | OLYMPUS NA-10J-KB ASPIRATION NEEDLE | FCG | Substantially Equivalent | |
| K984358 | OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 | FDS | Substantially Equivalent | |
| K992086 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 | JIX | Substantially Equivalent | |
| K990237 | TROCAR SYSTEM ACCORDING TO HASSON | GCJ | Substantially Equivalent | |
| K991136 | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM | JZG | Substantially Equivalent | |
| K984417 | BIPOLAR GRASPING FORCEPS BIQ+ | GEI | Substantially Equivalent | |
| K982323 | OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE | ITX | Substantially Equivalent | |
| K982725 | OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE | ITX | Substantially Equivalent | |
| K982289 | HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## | KNS | Substantially Equivalent | |
| K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | CKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2429304 | 2429304 | OLYMPUS Corporation of the Americas | 3500 CORPORATE PKWY., CENTER VALLEY, PA 18034 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- KNKAcid, Uric, Uricase (Colorimetric)
- CDOAcid, Uric, Uricase (U.V.)
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- HRXArthroscope
- JLBAtp And Creatine Kinase (Enzymatic), Creatine
- CJYAzo Dye, Calcium
- FCGBiopsy Needle
- CIXBromcresol Green Dye-Binding, Albumin
- EOQBronchoscope (Flexible Or Rigid)
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FDFColonoscope And Accessories, Flexible/Rigid
- DIHColorimetry, Cholinesterase
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- CICCresolphthalein Complexone, Calcium
- FAJCystoscope And Accessories, Flexible/Rigid
- FBOCystourethroscope
- FFLDislodger, Stone, Basket, Ureteral, Metal
- FDTDuodenoscope And Accessories, Flexible/Rigid
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- DBFFerritin, Antigen, Antiserum, Control
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- KGEForceps, Biopsy, Electric
- FCLForceps, Biopsy, Non-Electric
- FDSGastroscope And Accessories, Flexible/Rigid
- CFRHexokinase, Glucose
- FOGHood, Oxygen, Infant
- HIHHysteroscope (And Accessories)
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- EOBNasopharyngoscope (Flexible Or Rigid)
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- FDISnare, Flexible
- FGEStents, Drains And Dilators For The Biliary Ducts
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DCNSystem, Test, C-Reactive Protein
- DHXSystem, Test, Carcinoembryonic Antigen
- DHRSystem, Test, Rheumatoid Factor
- FFESystem, Water Jet Catheter, Renal
- ITXTransducer, Ultrasonic, Diagnostic
- DDDTransferrin, Rhodamine, Antigen, Antiserum, Control
- JHNTurbidimetric Method, Lipoproteins
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
- FGBUreteroscope And Accessories, Flexible/Rigid
- EZOUrethrotome
Recall records
Showing 25 of 436| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3035-2026 | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. | Class II | Open, Classified | |
| Z-2761-2026 | Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color. | Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities. | Class II | Open, Classified | |
| Z-2776-2026 | Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 | Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. | Class II | Open, Classified | |
| Z-2676-2026 | 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 | Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. | Class II | Open, Classified | |
| Z-2721-2026 | Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. | Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. | Class II | Open, Classified | |
| Z-2720-2026 | Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194. | Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. | Class II | Open, Classified | |
| Z-2719-2026 | Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. | Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. | Class II | Open, Classified | |
| Z-2718-2026 | Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. | Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. | Class II | Open, Classified | |
| Z-1909-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1908-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1907-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1906-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1905-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1904-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1903-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115. | XXX | Class II | Open, Classified | |
| Z-1902-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1901-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1900-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1899-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1898-2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE. | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Open, Classified | |
| Z-1854-2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. | Potential for detachment of a distal tip component of the device during use. | Class II | Open, Classified | |
| Z-1853-2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC. | Potential for detachment of a distal tip component of the device during use. | Class II | Open, Classified | |
| Z-1852-2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC. | Potential for detachment of a distal tip component of the device during use. | Class II | Open, Classified | |
| Z-1851-2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. | Potential for detachment of a distal tip component of the device during use. | Class II | Open, Classified | |
| Z-1695-2026 | Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No | Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain