FDA.reportPublic FDA data

Orion Vision

Matched from indexed company URL: Ori Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10665781000140384Orion Vision1N2026-01-011800 Sandy Plains Ind Prkwy Suite 310 Marietta GA US 30066
16468481000160256OriGen Biomedical, Inc.1N2026-01-017000 Burleson Rd. Bldg D Austin TX US 78744
19221021922102ORIENTAL TRADING CO.1Y2026-01-015455 S 90th Street OMAHA NE US 68127
80440043001227743ORIDION MEDICAL 1987 LTD.1N2026-01-017 HAMARPE ST. P.O. BOX 45025 JERUSALEM IL 9777407
30047765553004776555ORIENTAL INTERNATIONAL SUPPLIES LIMITED1N2026-01-0111/F., UNIT 1107, METRO CENTRE I 32 LAM HING ST., KOWLOON HK --
30053591613005359161ORION ENTERPRISES INC.1Y2026-01-011840 PICKWICK AVE. Glenview IL US 60026
30091295793009129579Oricare Inc.1Y2026-01-011900 Am Dr Quakertown PA US 18951
30100885633010088563ORIGIN MEDICAL DEVICES INC1N2026-01-0123 Corporate Plaza Suite 150 Newport Beach CA US 92660
30102755043010275504ORIENTAL RESOURCES DEVELOPMENT LIMITED1N2026-01-01No.30, Hexing Rd., Hukou Township Hsinchu TW 303
30108602453010860245ORIGAMI SURGICAL Inc.1N2026-01-0179 Haven St. Dover MA US 02030
30115129673011512967ORIENTECH ELECTRONICS(SUZHOU) CO., LTD1N2026-01-01426 XU JIANG ROAD SUZHOU Jiangsu CN 215400
30115411203011541120Oriol Cuch1N2026-01-012655 S Le Jeune Rd Ste 810 Miami FL US 33134
30132163873013216387ORIGEN TECHNOLOGIES LLC1Y2026-01-017041 Montrico Drive Boca Raton FL US 33433
30219874223021987422ORIHEALTH MEDICAL PRODUCTS(SUZHOU)CO.,LTD1N2026-01-01No.7 Xinmiao RD,New District,Taicang Suzhou Jiangsu CN 215400
30230064393023006439ORI INC1N2026-01-011064 S North County BLVD #430 Pleasant Grove UT US 84062
30272028463027202846Oricle Hearing LLC1Y2026-01-012400 Kettner Blvd Ste 238 San Diego CA US 92101
30285365603028536560ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD1N2026-01-01688 Bin'an Road Building 5, 12/F, Room 1208 Hangzhou Zhejiang CN 310000
30370064413037006441ORION MEDICAL SOLUTIONS1Y2026-01-011470 CAAP Dr Building 100, Suite 100 Watkinsville GA US 30677
30424847453042484745OriGen Biomedical, Inc.1Y2026-01-012215 Grand Avenue Pkwy Austin TX US 78728
00ORIENT NEO STAR INTELLIGENT TECHNOLOGY (DONG GUAN ) CO., LI5N2020-04-252/F, Building A, No.12 Keyuan Road, Tangxia Town Dongguan Guangdong CN 523710
00ORIGINAL NATIONS, LLC5Y2020-04-252171 El Camino Real Suite 211 Oceanside CA US 92054
00ORIGIN LABORATORIES5N2020-04-2575 14th ST San Francisco CA US 94103
11223301122330ORIGIO, Inc.1N2020-04-252400 HUNTERS WAY Charlottesville VA US 22911
30072640723007264072Oriver Co. LTD1N2020-04-25No.58,Lane 436,Sec.3 Chung-Shan Road Kuei-Jen Tainan - Municipality TW 711
30146529033014652903ORIENT DENTAL LABORATORY1N2020-04-251 Hang Cheng Street, 4th Floor Hesheng Building, Third Industrial Area, Jiuwei Shenzhen Guangdong CN 518126

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860008859501Ori - Intraoral Optical Scanning System385-429-3331support@oriscanning.com
00860008859501Ori - Intraoral Optical Scanning System801-367-2189support@oriscanning.com
00860008859518Ori - Intraoral Optical Scanning System801-367-2189support@oriscanning.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3384871267160778P980044SUPARTZ FXMOZ2001-01-24
3384871491129348P940015SYNVISC ONEMOZ1997-08-08
3384871380665019P170007DUROLANEMOZ2017-08-29
3384871198706572P150010HYMOVISMOZ2015-08-28
3384871586954119P140029Restylane Refyne, Restylane DefyneLMH2016-12-09
3384871093896809P110033JUVEDERM VOLUMA XCLMH2013-10-22
3384871879986421P110005SINOVIAL (SODIUM HYALURONATE 0.8%)MOZ2014-05-09
3384871052430833P090031MONOVISCMOZ2014-02-25
3384871664990754P050047JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTSLMH2006-06-02
3384871403080440P040024RESTYLANE INJECTABLE GELLMH2005-03-25
3384871630967763P030050SCULPTRA AND SCULPTRA AESTHETICLMH2004-08-03
3384871242024888P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONANMOZ2004-02-04
1902852045532364K993699THE STRIPPERMQH2000-05-16
776291890586928K992339COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENSLPL1999-08-16
776291766169387K991995SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENSMZD1999-08-27
1902852024309162K990847INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING MMQH1999-07-14
776291298518502K990815COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENSLPL1999-06-03
452331043247324K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
452331350882433K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
452331225192739K980325MICROSTREAM NASAL CANNULA FILTERLINECCK1998-04-16
452332030213928K980325MICROSTREAM NASAL CANNULA FILTERLINECCK1998-04-16
452331040328427K980324MICROSTREAM FILLERLINE OR/EMSCCK1998-04-16
452331064077375K980324MICROSTREAM FILLERLINE OR/EMSCCK1998-04-16
1902851265332309K915229SEMEN ANALYSIS KITPOV1994-08-30
3309781391031642K240401ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)HIH2024-07-26
452331701971253K230693BIS™ Advance Monitoring SystemOLW2024-02-26
3386081155784572K221052Self-Fitting hearing aidsQUH2023-09-25
452331332781116K213911Microstream CO2 NanoPodCCK2022-07-29
452331854091739K213518CARESCAPE CO2 Microstream parameterCCK2022-04-12
2931081141426664K213098Panther 5CBK2023-07-20
1688011681501395K211792StitchKitGAM2021-07-16
1688011512810775K202417
452331131392038K200594Capnostream 35 Portable Respiratory MonitorCCK2020-04-27
452331741329202K181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling LineCCK2019-03-22
452331639415304K181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter LineCCK2019-02-08
452331755861529K150272Capnostream 35 Portable Respiratory MonitorCCK2015-07-17
452331818637143K143506BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)GXY2015-04-16
1586661788219994K140913NUROS BONE GRAFT SUBSTITUTEMQV2015-02-17
1290132068342292K131790A9800 ANESTHESIA WORKSTATIONBSZ2014-05-09
1688011082861920K123811STITCHKITNBY2013-09-05
452331474717600K123690CAPNOSTREAM20P WITH HIFI C02 MONITORINGCCK2014-08-05
1290131180003130K122875ORICARE L2700FSY2012-12-18
452331724025104K121927MICROSTREAM FILTERLINE ICUCCK2012-11-29
452331739774436K121927MICROSTREAM FILTERLINE ICUCCK2012-11-29
1290131094266218K120931CRITICAL CARE VENTILATORCBK2013-06-06
1290131095256851K113338MEDICAL AIR COMPRESSORBTI2012-08-10
452331769463335K112368CAPNOSTREAM20P WITH AI/ODICCK2012-07-19
452331526028328K094012CAPNOSTREAM20 WITH MICROMEDICO2 MODULECCK2010-05-12
452331185709834K093388SMART CAPNOLINE GUARDIANCCK2010-03-04
452331210280950K093388SMART CAPNOLINE GUARDIANCCK2010-03-04
452331451692542K082268CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEXDQA2009-02-06
452331005115521K072295CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWAREDQA2007-10-11
452331203101264K072286BIS EEG VISTA MONITOR SYSTEM AND BISXOLW2007-11-20
452331203840460K060065CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITORDQA2006-05-04
452331419666754K042665SMART BITEBLOCCCK2004-11-23
1902851033281479K041435THE STRIPPER PGDMQH2004-09-29
769721459837591K021702CRYOBAG, MODEL CBLPZ2002-08-06
3453901459837591K021702CRYOBAG, MODEL CBLPZ2002-08-06
452332045988429K013845MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINECCK2001-11-29
452332046298608K013845MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINECCK2001-11-29
1902851233292258K012811BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-BMQH2002-02-11
452331028429954K012395MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15
452331146082176K012395MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15
452331086954347K012394ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINECCK2001-08-15
452331923950138K012394ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINECCK2001-08-15
452331024457092K012391MAC-LINE CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15
452331789199494K012391MAC-LINE CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15
452331285625041K011536MICROSTREAM O2/CO2 ORAL NASAL FILTERLINECCK2001-11-14
452331643219718K011536MICROSTREAM O2/CO2 ORAL NASAL FILTERLINECCK2001-11-14
452331466793430K011050MICROSTREAM ORAL NASAL CANNULA FILTERLINECCK2001-05-04
452332070118951K011050MICROSTREAM ORAL NASAL CANNULA FILTERLINECCK2001-05-04
452331676338625K010024O2/CO2 NASAL FILTERLINECCK2001-03-14
452332069244467K010024O2/CO2 NASAL FILTERLINECCK2001-03-14
1806871289129105K003748TIANXIEMQX2001-01-26
776292042076006K002647MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENSLPL2000-09-13
452331884538529K002163MICROSTREAM EXTERNAL BATTERY CHARGERCCK2001-01-11
1902851829450965K000915PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75MQK2000-05-12
769721483151941BK180278
3453901483151941BK180278
769721535937335BK140116
769721138116192BK030036
3453901138116192BK030036
2200581019231613
1290131046387585
2594181132737422
1048041306983701
2200581339385027
1048041356691335
2200581370232622
769721390870020
1586661391530033
452331395916702
1586661404679477
769721476841500
769721556631764
2200581695879895
1048041704193374
2200581711908491
1048041831890623
2200581861911860
1048041921693327
2419321923820222
2200581970086167
2594182011369343
241591031089785
241591047773609
452331078884436
1806871091742701
241591098732242
769721147384064

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CCK362022-07-29
MOZ72017-08-29
LMH52016-12-09
MQH42004-09-29
CBK32023-07-20
DQA32009-02-06
LPZ32002-08-06
LPL32000-09-13
OLW22024-02-26
BSZ22014-05-09
FSY22012-12-18
BTI22012-08-10
MQX22001-01-26
HIH12024-07-26
QUH12023-09-25
GAM12021-07-16
GXY12015-04-16
MQV12015-02-17
NBY12013-09-05
MQK12000-05-12
MZD11999-08-27
POV11994-08-30

NDC#

PMN#

200 records. Showing 1-40. Next

Applications#

GUDID#