510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Olympus Corp.

Melville, NY, US

Olympus Corp. appears in FDA device records in Melville, NY. FDA records list 149 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
149
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 149

FDA records hold 149 510(k) clearances for Olympus Corp. between 1978 and 2007. The busiest year on record is 1992, with 43. The most recent is 2007, with 1.

Clearances by year, as a table
510(k) clearance decisions for Olympus Corp., by decision year
YearClearances
19783
19791
19802
19811
19832
19858
19864
19875
19883
19896
199010
199121
199243
199325
19948
19952
20044
20071
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K072643CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/USKZNSubstantially Equivalent
K043128OLYMPUS ENDOARMGWGSubstantially Equivalent
K042140OLYMPUS BF TYPE UC160-OL8ODGSubstantially Equivalent
K041494OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2FETSubstantially Equivalent
K040940BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HMEOQSubstantially Equivalent
K915402EW-10 AND EW-20FEBSubstantially Equivalent for Some Indications
K933200OLYMPUS PBD STENTSFGESubstantially Equivalent
K942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESFDTSubstantially Equivalent
K931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSFASSubstantially Equivalent
K934835FLOVALFJLSubstantially Equivalent
K931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCESHIHSubstantially Equivalent
K915857FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPEHETSubstantially Equivalent
K931994RESECTOSCOPE SHEATHHIHSubstantially Equivalent
K934889OLYMPUS IMAGEMANAGER SYSTEMLMBSubstantially Equivalent
K934888OLYMPUS IMAGEMANAGERSYSTEMLMBSubstantially Equivalent
K933992OLYMPUS SCLEROTHERAPY BALLOONKNQSubstantially Equivalent
K934361OLYMPUS CREATININE REAGENTCGXSubstantially Equivalent
K934136OLYMPUS CHLORIDE REAGENT, MODIFICATIONCHJSubstantially Equivalent
K933110OLYMPUS GUIDE WIREOCYSubstantially Equivalent
K933717OLYMPUS MEASURING DEVICESFDSSubstantially Equivalent
K931301OLYMPUS AMYLASE REAGENTCIJSubstantially Equivalent
K931154EVIS 200 SYSTEMEOQSubstantially Equivalent
K931939OLYMPUS CREATININE REAGENTCGXSubstantially Equivalent
K932528OLYMPUS CHLORID REAGENT, MODIFIEDCHJSubstantially Equivalent
K931835OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENTCEOSubstantially Equivalent
K931744OLYMPUS REPLY GLUCOSE REAGENTJJESubstantially Equivalent
K931745OLYMPUS REPLY UREA NITROGEN REAGENTCDQSubstantially Equivalent
K926514ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20ODGSubstantially Equivalent
K931995RESECTOSCOPE SHEATHFJLSubstantially Equivalent
K925935OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZERJJQSubstantially Equivalent
K930241OLYMPUS DISPOSABLE BIOPSY FORCEPSKNWSubstantially Equivalent
K930215FLEXIBLE TROCAR TUBESEWYSubstantially Equivalent
K923982OLYMPUS OES LAPAROSCOPY SYSTEMGCJSubstantially Equivalent
K925603OLYMPUS CHOLESTEROL REAGENTCHHSubstantially Equivalent
K924368OLYMPUS ALBUMIN REAGENTCIXSubstantially Equivalent
K925339OLYLMPUS ALANINE AMINOTRANSFERASE REAGENTCKASubstantially Equivalent
K925337OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENTJQBSubstantially Equivalent
K925155OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENTCITSubstantially Equivalent
K925113OLYMPUS URIC ACID REAGENTKNKSubstantially Equivalent
K924832OLYMPUS CREATINE KINASE REAGENTCGSSubstantially Equivalent
K924659OLYUMPUS TOTAL PROTEIN REAGENTCEKSubstantially Equivalent
K924691OLYMPUS IRON REAGENTJIYSubstantially Equivalent
K925338OLYMPUS CHLORIDE REAGENTCHJSubstantially Equivalent
K924964OLYMPUS TOTAL BILIRUBIN REAGENTCIGSubstantially Equivalent
K924601OLYMPUS GLUCOSE REAGENTCFRSubstantially Equivalent
K924963OLYMPUS DIRECT BILIRUBIN REAGENTCIGSubstantially Equivalent
K924693OLYMPUS BUN REAGENTCDQSubstantially Equivalent
K925057OLYMPUS INORGANIC PHOSPHORUS REAGENTCEOSubstantially Equivalent
K925156OLYMPUS ALKALINE PHOSPHATASE REAGENTCJESubstantially Equivalent
K922231OLYMPUS CHOLESTEROL REAGENTCHHSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Olympus Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Olympus Corp.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of , FDA export datePage updated Source: openFDA, public domain