Oculus Optikgerate G M B H

FDA Filings

This page includes the latest FDA filings for Oculus Optikgerate G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9611269
• FEI Number: 3002807782
• Name: OCULUS OPTIKGERATE GMBH
• Owner & Operator: OCULUS OPTIKGERATE GMBH
• Contact Address: Muenchholzhaeuser Str. 29 --; WETZLAR DE-NOTA D-35582 DE
• US Agent:
  • Michael Wolber
  • OCULUS, INC.
  • 360 6709977
  • 360 6700742
  • mwolber@oculususa.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: MUNCHHOLZHAUSER STR. 29 ; WETZLAR Hessen, D-35582 DE
• Establishment Type: Manufacture Medical Device

• Registration Number: 3009773841
• FEI Number: 3009773841
• Name: OCULUS Florida Service Center
• Owner & Operator: OCULUS OPTIKGERATE GMBH
• Contact Address: Muenchholzhaeuser Str. 29 --; WETZLAR DE-NOTA D-35582 DE
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 562 NW Mercantile Pl Ste 104 ; Port Saint Lucie, FL 34986 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3033566
• FEI Number: 3002785343
• Name: OCULUS, INC.
• Owner & Operator: OCULUS OPTIKGERATE GMBH
• Contact Address: Muenchholzhaeuser Str. 29 --; WETZLAR DE-NOTA D-35582 DE
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 17721 59th Avenue NE ; Arlington, WA 98223 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K201724 OCULUS Optikgerate GmbH	Pentacam AXL Wave	2020-10-21
HLG OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Vissard 3D, Vissard MOBIL	2016-09-05
HLG OCULUS OPTIKGERATE GMBH	Vissard 3D, Vissard MOBIL	2016-09-05
HLG OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Vissard 3D, Vissard MOBIL	2016-09-05
PMN K152311 | MXK OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Pentacam AXL	2016-01-29
PMN K152311 | MXK OCULUS OPTIKGERATE GMBH	Pentacam AXL	2016-01-29
PMN K152311 | MXK OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Pentacam AXL	2016-01-29
PMN K152311 OCULUS OPTIKGERATE GMBH	Pentacam AXL	2016-01-20
HRJ OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Hubtische	2013-09-07
HRJ OCULUS OPTIKGERATE GMBH	Hubtische	2013-09-07
HRJ OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Hubtische	2013-09-07
HJQ OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Binoptometer	2013-09-07
HJQ OCULUS OPTIKGERATE GMBH	Binoptometer	2013-09-07
HJQ OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Binoptometer	2013-09-07
KQM OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Imagecam2	2013-08-27
KQM OCULUS OPTIKGERATE GMBH	Imagecam2	2013-08-27
KQM OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Imagecam2	2013-08-27
PMN K113066 | MXK OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Corvis STL	2012-12-19
PMN K113066 | MXK OCULUS OPTIKGERATE GMBH	Corvis STL	2012-12-19
PMN K113066 | MXK OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Corvis STL	2012-12-19
PMN K113066 | HKX OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Corvis STL	2012-12-19
PMN K113066 | HKX OCULUS OPTIKGERATE GMBH	Corvis STL	2012-12-19
PMN K113066 | HKX OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Corvis STL	2012-12-19
PMN K113066 OCULUS OPTIKGERATE GMBH	CORVIS ST	2012-11-08
HIT OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Ishihara	2011-08-26
HIT OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Color Vision Tester	2011-08-26
HIT OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	C-Quant	2011-08-26
HIT OCULUS OPTIKGERATE GMBH	Ishihara	2011-08-26
HIT OCULUS OPTIKGERATE GMBH	Color Vision Tester	2011-08-26
HIT OCULUS OPTIKGERATE GMBH	C-Quant	2011-08-26
HIT OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Ishihara	2011-08-26
HIT OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Color Vision Tester	2011-08-26
HIT OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	C-Quant	2011-08-26
HIW OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Anomaloscope	2011-08-16
HIW OCULUS OPTIKGERATE GMBH	Anomaloscope	2011-08-16
HIW OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Anomaloscope	2011-08-16
PMN K073508 | MXK OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	PARK	2010-06-08
PMN K073508 | MXK OCULUS OPTIKGERATE GMBH	PARK	2010-06-08
PMN K073508 | MXK OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	PARK	2010-06-08
PMN K073508 | HLQ OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	PARK	2010-06-08
PMN K073508 | HLQ OCULUS OPTIKGERATE GMBH	PARK	2010-06-08
PMN K073508 | HLQ OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	PARK	2010-06-08
PMN K073508 | HKO OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	PARK	2010-06-08
PMN K073508 | HKO OCULUS OPTIKGERATE GMBH	PARK	2010-06-08
PMN K073508 | HKO OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	PARK	2010-06-08
PMN K030719 | MXK OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Pentacam	2010-06-08
PMN K030719 | MXK OCULUS OPTIKGERATE GMBH	Pentacam	2010-06-08
PMN K030719 | MXK OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Pentacam	2010-06-08
PMN K073508 OCULUS OPTIKGERATE GMBH	PARKONE	2008-09-11
PMN K041841 | MXK OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	PACHYCAM	2006-09-27
PMN K041841 | MXK OCULUS OPTIKGERATE GMBH	PACHYCAM	2006-09-27
PMN K041841 | MXK OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	PACHYCAM	2006-09-27
PMN K041841 OCULUS OPTIKGERATE GMBH	PACHYCAM	2005-01-28
HRM OCULUS OPTIKGERATE GMBH	TER	2004-04-26
HRM OCULUS OPTIKGERATE GMBH	STEREO DIAGNOSTIC INVERTER	2004-04-26
HRM OCULUS OPTIKGERATE GMBH	BINOCULAR INDIRECT OPHTHALMO MICROS	2004-04-26
PMN K030719 OCULUS OPTIKGERATE GMBH	PENTACAM SCHEIMPFLUG CAMERA	2003-09-16
MMQ OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Keratograph	2000-07-11
MMQ OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Keratograph 5	2000-07-11
MMQ OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Keratograph 4	2000-07-11
MMQ OCULUS OPTIKGERATE GMBH	Keratograph	2000-07-11
MMQ OCULUS OPTIKGERATE GMBH	Keratograph 5	2000-07-11
MMQ OCULUS OPTIKGERATE GMBH	Keratograph 4	2000-07-11
MMQ OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Keratograph	2000-07-11
MMQ OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Keratograph 5	2000-07-11
MMQ OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Keratograph 4	2000-07-11
HPT OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Perimeter	2000-07-11
HPT OCULUS OPTIKGERATE GMBH	Perimeter	2000-07-11
HPT OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Perimeter	2000-07-11
HOH OCULUS OPTIKGERATE GMBH	Lens Ophthalmic, Reduction lens, Optic Set HD	1986-06-09
HJJ OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	FRESNEL	1983-09-27
HJJ OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	FLEXIBLE DIAGNOSTIC	1983-09-27
HJJ OCULUS OPTIKGERATE GMBH	FRESNEL	1983-09-27
HJJ OCULUS OPTIKGERATE GMBH	FLEXIBLE DIAGNOSTIC	1983-09-27
HJJ OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	FRESNEL	1983-09-27
HJJ OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	FLEXIBLE DIAGNOSTIC	1983-09-27
HPD OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Lens, Bagolini	1978-04-20
HPD OCULUS OPTIKGERATE GMBH	Lens, Bagolini	1978-04-20
HPD OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Lens, Bagolini	1978-04-20
HPC OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Set, Lens, Trail	1978-04-20
HPC OCULUS OPTIKGERATE GMBH	Set, Lens, Trail	1978-04-20
HPC OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Set, Lens, Trail	1978-04-20
HPA OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Frame, Trial, Ophthalmic	1978-04-20
HPA OCULUS OPTIKGERATE GMBH	Frame, Trial, Ophthalmic	1978-04-20
HPA OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Frame, Trial, Ophthalmic	1978-04-20
HOX OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Vissard 3D, Vissard MOBIL	1978-04-20
HOX OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Chart, Visual Acuity	1978-04-20
HOX OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	C-Quant	1978-04-20
HOX OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Binoptometer	1978-04-20
HOX OCULUS OPTIKGERATE GMBH	Vissard 3D, Vissard MOBIL	1978-04-20
HOX OCULUS OPTIKGERATE GMBH	Chart, Visual Acuity	1978-04-20
HOX OCULUS OPTIKGERATE GMBH	C-Quant	1978-04-20
HOX OCULUS OPTIKGERATE GMBH	Binoptometer	1978-04-20
HOX OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Vissard 3D, Vissard MOBIL	1978-04-20
HOX OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Chart, Visual Acuity	1978-04-20
HOX OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	C-Quant	1978-04-20
HOX OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Binoptometer	1978-04-20
HOO OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Twinfield	1978-04-20
HOO OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Twinfield 2	1978-04-20
HOO OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Smartfield	1978-04-20
HOO OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Easyfield S	1978-04-20
HOO OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Easyfield C	1978-04-20
HOO OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Centerfield 2	1978-04-20
HOO OCULUS OPTIKGERATE GMBH	Twinfield	1978-04-20
HOO OCULUS OPTIKGERATE GMBH	Twinfield 2	1978-04-20
HOO OCULUS OPTIKGERATE GMBH	Smartfield	1978-04-20
HOO OCULUS OPTIKGERATE GMBH	Easyfield S	1978-04-20
HOO OCULUS OPTIKGERATE GMBH	Easyfield C	1978-04-20
HOO OCULUS OPTIKGERATE GMBH	Centerfield 2	1978-04-20
HOO OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Twinfield	1978-04-20
HOO OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Twinfield 2	1978-04-20
HOO OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Smartfield	1978-04-20
HOO OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Easyfield S	1978-04-20
HOO OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Easyfield C	1978-04-20
HOO OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Centerfield 2	1978-04-20
HOI OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	MAGNIFYING SPECTACLE	1978-04-20
HOI OCULUS OPTIKGERATE GMBH	MAGNIFYING SPECTACLE	1978-04-20
HOI OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	MAGNIFYING SPECTACLE	1978-04-20
HLS OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Exophthalmometer	1978-04-20
HLS OCULUS OPTIKGERATE GMBH	Exophthalmometer	1978-04-20
HLS OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Exophthalmometer	1978-04-20
HJH OCULUS, INC. [OCULUS OPTIKGERATE GMBH]	Loupe Binocular	1978-04-20
HJH OCULUS OPTIKGERATE GMBH	Loupe Binocular	1978-04-20
HJH OCULUS Florida Service Center [OCULUS OPTIKGERATE GMBH]	Loupe Binocular	1978-04-20

Similar & Related FDA Registered Companies

• OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020041159031	Bremerhaven,Federal Republic of Germany -> Miami, Florida	OPTICAL OPHTHALMIC	17 PKG
2019121760247	Stadersand,Federal Republic of Germany -> Port Everglades, Florida	BIOM OPTIC SET HD PROFESSIONAL	22 PCS