Olympus America Inc

FDA Filings

This page includes the latest FDA filings for Olympus America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Olympus America Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)

FDA Filings

Device Company	Device	Date
Indocyanine Green Olympus America, Inc.	Prescription Medication	2023-06-20
NDC 73624-424 Olympus America, Inc.	Indocyanine Green	2021-04-01
Indocyanine Green Olympus America, Inc.	Prescription Medication	2021-04-01
PMN K111788 OLYMPUS AMERICA, INC.	ENDOEYE HD II	2012-01-13
PMN K081615 OLYMPUS AMERICA, INC.	OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN	2009-03-18
PMN K073490 OLYMPUS AMERICA INC.	OLYMPUS IGG REAGENT	2008-02-11
PMN K073489 OLYMPUS AMERICA INC.	OLYMPUS IGA REAGENT	2008-02-11
PMN K073487 OLYMPUS AMERICA INC.	OLYMPUS IGM REAGENT	2008-02-11
PMN K062862 OLYMPUS AMERICA, INC.	OLYMPUS URIC ACID REAGENT, MODEL OSR6X98	2007-04-06
PMN K063804 OLYMPUS AMERICA, INC.	OLYMPUS TRIGLYCERIDE TEST SYSTEM	2007-03-23
PMN K061499 OLYMPUS AMERICA, INC.	OSFERION	2007-01-26
PMN K062581 OLYMPUS AMERICA, INC.	OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM	2006-11-29
PMN K061575 OLYMPUS AMERICA, INC.	OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117	2006-10-05
PMN K060201 OLYMPUS AMERICA, INC.	OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.	2006-06-06
PMN K051564 OLYMPUS AMERICA, INC.	OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH	2005-08-22
PMN K051541 OLYMPUS AMERICA, INC.	GF-UE160-AL5 ULTRASOUND ENDOSCOPE	2005-07-01
PMN K043460 OLYMPUS AMERICA, INC.	OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071	2005-01-31
PMN K043202 OLYMPUS AMERICA, INC.	OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279	2004-12-23
PMN K041793 OLYMPUS AMERICA, INC.	OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524	2004-07-16
PMN K040692 OLYMPUS AMERICA, INC.	OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023	2004-04-08
PMN K040471 OLYMPUS AMERICA, INC.	OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024	2004-03-10
PMN K032665 OLYMPUS AMERICA, INC.	OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071	2003-11-21
PMN K031380 OLYMPUS AMERICA, INC.	OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)	2003-11-14
PMN K032285 OLYMPUS AMERICA, INC.	OLYMPUS PREALBUMIN CALIBRATOR, ODR3029	2003-08-21
PMN K030045 OLYMPUS AMERICA, INC.	OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)	2003-02-21
PMN K030124 OLYMPUS AMERICA, INC.	OLYMPUS FERRITIN REAGENT	2003-02-06
PMN K021074 OLYMPUS AMERICA, INC.	VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA	2002-05-02
PMN K021073 OLYMPUS AMERICA, INC.	VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V	2002-05-01
PMN K014032 OLYMPUS AMERICA, INC.	OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA	2002-02-08
PMN K014015 OLYMPUS AMERICA, INC.	OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA	2002-02-08
PMN K013066 OLYMPUS AMERICA, INC.	HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE	2001-12-11
PMN K011886 OLYMPUS AMERICA, INC.	OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,	2001-08-27
PMN K011720 OLYMPUS AMERICA, INC.	OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER	2001-06-25
PMN K001744 OLYMPUS AMERICA, INC.	OLYMPUS ENDOSCOPIC LIGATION DEVICE	2001-02-27
PMN K003721 OLYMPUS AMERICA, INC.	MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	2000-12-18
PMN K002982 OLYMPUS AMERICA, INC.	OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	2000-10-25
PMN K002918 OLYMPUS AMERICA, INC.	OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT	2000-10-25
PMN K994103 OLYMPUS AMERICA, INC.	OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT	2000-09-05
PMN K994106 OLYMPUS AMERICA, INC.	OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE	2000-06-02
PMN K994069 OLYMPUS AMERICA, INC.	OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE	2000-06-02
PMN K991672 OLYMPUS AMERICA, INC.	OLYMPUS NA-10J-KB ASPIRATION NEEDLE	1999-11-03
PMN K984358 OLYMPUS AMERICA, INC.	OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597	1999-09-17
PMN K992086 OLYMPUS AMERICA, INC.	OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2	1999-08-19
PMN K990237 OLYMPUS AMERICA, INC.	TROCAR SYSTEM ACCORDING TO HASSON	1999-07-12
PMN K991136 OLYMPUS AMERICA, INC.	B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM	1999-05-11
PMN K984417 OLYMPUS AMERICA, INC.	BIPOLAR GRASPING FORCEPS BIQ+	1999-02-24
PMN K982323 OLYMPUS AMERICA, INC.	OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE	1998-12-11
PMN K982725 OLYMPUS AMERICA, INC.	OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE	1998-10-23
PMN K982289 OLYMPUS AMERICA, INC.	HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##	1998-08-19
PMN K981743 OLYMPUS AMERICA, INC.	OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER	1998-06-09
PMN K981305 OLYMPUS AMERICA, INC.	OLYMPUS SERUM PROTEIN MULTICALIBRATOR	1998-05-07
PMN K980465 OLYMPUS AMERICA, INC.	OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS	1998-04-21
PMN K973128 OLYMPUS AMERICA, INC.	OLYMPUS NA-10J-1 ASPIRATION NEEDLE	1997-11-18
PMN K964661 OLYMPUS AMERICA, INC.	HX-20/21-1 ENDOSCOPIC LIGATOR	1997-10-30
PMN K971660 OLYMPUS AMERICA, INC.	OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT	1997-07-25
PMN K971416 OLYMPUS AMERICA, INC.	OLYMPUS OES OTV-S5C VIDEO SYSTEM	1997-07-16
PMN K971328 OLYMPUS AMERICA, INC.	OLYMPUS CD-6C-1 COAGULATION ELECTRODE	1997-07-01
PMN K963160 OLYMPUS AMERICA, INC.	HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE	1997-06-27
PMN K971817 OLYMPUS AMERICA, INC.	OLYMPUS CK-MB REAGENT	1997-06-11
PMN K970797 OLYMPUS AMERICA, INC.	OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES	1997-05-28
PMN K960068 OLYMPUS AMERICA, INC.	SH-1 SURGICAL HOLDER FOR TELESCOPE	1997-05-05
PMN K970563 OLYMPUS AMERICA, INC.	OLYMPUS NA-10J-1 ASPIRATION NEEDLE	1997-04-11
PMN K970184 OLYMPUS AMERICA, INC.	OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES	1997-04-11
PMN K954488 OLYMPUS AMERICA, INC.	ROLLER ELECTRODE	1997-03-06
PMN K963640 OLYMPUS AMERICA, INC.	OLYMPUS ACID PHOSPHATASE REAGENT	1997-02-18
PMN K963023 OLYMPUS AMERICA, INC.	ULTRASOUND GASTROSCOPE GF TYPE UM30P	1997-02-07
PMN K963139 OLYMPUS AMERICA, INC.	OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT	1997-02-06
PMN K963424 OLYMPUS AMERICA, INC.	OLYMPUS LIPASE REAGENT	1997-01-14
PMN K963184 OLYMPUS AMERICA, INC.	OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM	1996-12-31
PMN K962474 OLYMPUS AMERICA, INC.	OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)	1996-12-20
PMN K950719 OLYMPUS AMERICA, INC.	OES UROLOGY	1996-12-11
PMN K963170 OLYMPUS AMERICA, INC.	OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT	1996-12-02
PMN K962925 OLYMPUS AMERICA, INC.	OLYMPUS B-5/B-7 SERIESBALLOON CATHETER	1996-10-25
PMN K962582 OLYMPUS AMERICA, INC.	OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT	1996-10-18
PMN K962409 OLYMPUS AMERICA, INC.	OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT	1996-10-18
PMN K961048 OLYMPUS AMERICA, INC.	OLYMPUS MH-246R BALLOON SHEATH	1996-09-16
PMN K963033 OLYMPUS AMERICA, INC.	BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES	1996-09-09
PMN K961860 OLYMPUS AMERICA, INC.	A4907 LENS CLEANING SHEATH	1996-08-29
PMN K962901 OLYMPUS AMERICA, INC.	OLYMPUS B5-2C/B7-2C BALLOON CATHETER	1996-08-20
PMN K962485 OLYMPUS AMERICA, INC.	OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)	1996-08-20
PMN K962533 OLYMPUS AMERICA, INC.	OLYPUS FG SERIES GRASPING FORCEPS	1996-08-09
PMN K962380 OLYMPUS AMERICA, INC.	OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)	1996-08-09
PMN K962367 OLYMPUS AMERICA, INC.	OLYMPUS BASKET GRASPERS	1996-08-05
PMN K962378 OLYMPUS AMERICA, INC.	OLYMPUS FG-45/46-1 GRASPING FORCEPS	1996-08-02
PMN K962387 OLYMPUS AMERICA, INC.	OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)	1996-07-31
PMN K962555 OLYMPUS AMERICA, INC.	OLYMPUS FB SERIES BIOPSY FORCEPS	1996-07-30
PMN K961611 OLYMPUS AMERICA, INC.	OLYMPUS BASKET GRASPERS (UROLOGY)	1996-07-18
PMN K961274 OLYMPUS AMERICA, INC.	OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER	1996-07-05
PMN K955247 OLYMPUS AMERICA, INC.	OLYMPUS KD SERIES SPHINCTEROTOME	1996-04-30
PMN K951994 OLYMPUS AMERICA, INC.	OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER	1996-04-15
PMN K955650 OLYMPUS AMERICA, INC.	OLYMPUS SD SERIES SNARES	1996-03-29
PMN K954451 OLYMPUS AMERICA, INC.	EVIS 140 SYSTEM	1996-03-29
PMN K955403 OLYMPUS AMERICA, INC.	OES LAPARO-THORACO VIDEOSCOPE TYPE V	1996-03-11
PMN K955456 OLYMPUS AMERICA, INC.	OES LAPARO-THORACO VIDEOSCOPE (RIGID)	1996-02-22
PMN K954537 OLYMPUS AMERICA, INC.	OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT	1996-02-14
PMN K955623 OLYMPUS AMERICA, INC.	OLYMPUS BIPOLAR FORCEPS	1996-02-13
PMN K955139 OLYMPUS AMERICA, INC.	OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT	1996-02-12
PMN K952892 OLYMPUS AMERICA, INC.	OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)	1996-02-12
PMN K955404 OLYMPUS AMERICA, INC.	OTV-S5 OES VIDEO SYSTEM	1996-02-01

Similar & Related FDA Registered Companies

Related Finance Registrations

NCAGE Code	03NS9	OLYMPUS AMERICA INC
NCAGE Code	06GN2	OLYMPUS AMERICA INC
NCAGE Code	0HFT1	OLYMPUS AMERICA INC
NCAGE Code	0JD93	OLYMPUS AMERICA INC
NCAGE Code	0JPU9	OLYMPUS AMERICA INC
NCAGE Code	1C1R2	OLYMPUS AMERICA INC
NCAGE Code	1E1Q5	OLYMPUS AMERICA INC
NCAGE Code	1KY21	OLYMPUS AMERICA INC.
NCAGE Code	6SDT8	OLYMPUS AMERICA INC.
NCAGE Code	1KN63	OLYMPUS AMERICA, INC.!DBA SEG
NCAGE Code	32212	OLYMPUS AMERICA INC.!DBA MEDICAL SYSTEMS GROUP!DIV MEDICAL SYSTEMS GROUP
CAGE Code	03NS9	OLYMPUS AMERICA INC
CAGE Code	06GN2	OLYMPUS AMERICA INC
CAGE Code	0HFT1	OLYMPUS AMERICA INC
CAGE Code	0JD93	OLYMPUS AMERICA INC
CAGE Code	0JPU9	OLYMPUS AMERICA INC
CAGE Code	1C1R2	OLYMPUS AMERICA INC
CAGE Code	1E1Q5	OLYMPUS AMERICA INC LATIN AMERICAN
CAGE Code	1K6L5	OLYMPUS AMERICA INC ENDOSCOPY GROUP/SURGICAL PRODUCT(SP)
CAGE Code	1KN63	OLYMPUS AMERICA, INC. SEG
CAGE Code	1KY21	OLYMPUS AMERICA INC.
CAGE Code	6SDT8	OLYMPUS AMERICA INC.
CAGE Code	32212	OLYMPUS AMERICA INC. MEDICAL SYSTEMS GROUP MEDICAL SYSTEMS GROUP
CAGE Code	4X771	OLYMPUS AMERICA INC OLYMPUS MEDICAL EQUIPMENT SERVICES
CAGE Code	9W200	OLYMPUS AMERICA INC DIAGNOSTIC SYSTEMS GROUP
S.A.M. Registration	32212 [17018859]	OLYMPUS AMERICA INC. MEDICAL SYSTEMS GROUP
S.A.M. Registration	6SDT8 [19262873]	OLYMPUS AMERICA INC.
S.A.M. Registration	1KY21 [125103460]	OLYMPUS AMERICA INC.
S.A.M. Registration	1KN63 [17019618]	OLYMPUS AMERICA, INC. SEG
DUNS	967886938	OLYMPUS AMERICA INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092611681	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	ENDOSCOPIC EQUIPMENT(S)	960 CTN
2020092611681	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	ENDOSCOPIC EQUIPMENT(S)	960 CTN
202009235999	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	ENDOSCOPIC EQUIPMENT(S)	216 CTN
202009196019	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	ENDOSCOPIC EQUIPMENT(S)	104 CTN
202009195926	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	DIGITAL STILL CAMERA(S) AND ACCESSORY(IES) DIGITAL AUDIO PLAYER AND ACCESSORY(IES) BINOCULAR(S)	680 CTN
2020091420492	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	ENDOSCOPIC EQUIPMENT(S)	216 CTN
2020091010739	Tsingtao,China (Mainland) -> New York/Newark Area, Newark, New Jersey	OLYMPUS PRODUCTS	100 CTN
2020090916054	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	DIGITAL STILL CAMERA(S) AND ACCESSORY(IES) DIGITAL AUDIO PLAYER AND ACCESSORY(IES) BINOCULAR(S)	680 CTN
2020090916284	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	ENDOSCOPIC EQUIPMENT(S)	104 CTN