OXYGEN
OXYGEN
Reg
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1058743 | 1000307739 | REGENT LABS, INC. | 1 | N | 2026-01-01 | 473 GOOLSBY BLVD. Deerfield Bch FL US 33442 |
| 2032108 | 3003070149 | REGENESIS BIOMEDICAL, INC. | 1 | N | 2026-01-01 | 5301 N Pima Rd Ste 150 SCOTTSDALE AZ US 85250 |
| 3003746954 | 3003746954 | Regina Kan | 1 | N | 2026-01-01 | 2355 longden drive San Marino CA US 91108 |
| 3004646509 | 3004646509 | REGAL PROSTHESIS LIMITED | 1 | N | 2026-01-01 | Room 3D Mai Luen Industrial Building 23-31 Kung Yip Street Kwai Chung NT HK - |
| 3008496303 | 3008496303 | REGEN LAB Sa | 1 | N | 2026-01-01 | EN BUDRON B2 LE MONT-SUR-LAUSANNE Vaud CH 1052 |
| 3010050274 | 3010050274 | REGENERATIVE TECHNOLOGIES CORP dba JUVENT | 1 | N | 2026-01-01 | 9420 Ooltewah Industrial Road Suite 1 Ooltewah TN US 37363 |
| 3010388471 | 3010388471 | Regina Gendelman | 1 | N | 2026-01-01 | 12405 Montague Street Pacoima CA US 91331 |
| 3010512490 | 3010512490 | Regenlab USA LLC | 1 | Y | 2026-01-01 | 95 Greene St Jersey City NJ US 07302 |
| 3011387885 | 3011387885 | REGENMED SYSTEMS INC. | 1 | N | 2026-01-01 | 633 Silver Avenue Half Moon Bay CA US 94019 |
| 3012404027 | 3012404027 | REGENT ELECTRON SUZHOU CO., LTD | 1 | N | 2026-01-01 | NO.888.Ganquan Dong Road, Economic development zone Wujiang Jiangsu CN 215200 |
| 3015927859 | 3015927859 | REGINA MIRACLE INTERNATIONAL (VIET NAM) CO., LTD | 1 | N | 2026-01-01 | No.9, East West Road, VSIP Hai Phong Township, Industrial and Se Duong Quan Commune, Thuy Nguyen District Haiphong Hai Phong VN 180000 |
| 3018228712 | 3018228712 | Regen Suppliers LLC | 1 | N | 2026-01-01 | 10045 East Dynamite Boulevard Suite 260 Scottsdale AZ US 85262 |
| 3030748032 | 3030748032 | REGEN MEDICAL LLC | 1 | Y | 2026-01-01 | 2300 W Sahara Ave Ste 800 Las Vegas NV US 89102 |
| 3002627297 | 3002627297 | Registrar Corp | 1 | N | 2020-04-25 | 144 Research Drive Hampton VA US 23666 |
| 3005801809 | 3005801809 | Regal Research & Manufacturing Co | 1 | N | 2020-04-25 | 1200 E Plano Pkwy Plano TX US 75074 |
| 3016637341 | 3016637341 | REGALIA STORE FIXTURES GROUP LLC | 1 | Y | 2020-04-25 | 1 STS Drive Bridgewater NJ US 08807 |
| 3016722879 | 3016722879 | REGENESYS | 1 | N | 2020-04-25 | 6300 Fairlane Dr Oakland CA US 94611 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 164668 | 1120591732 | K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | 1999-05-28 |
| 164668 | 1265501701 | K965202 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET | JKA | 1997-02-10 |
| 53583 | 1013580424 | K223620 | Reprieve by RegenesisTM | IMJ | 2023-05-24 |
| 164668 | 1361926290 | K173577 | Guarded Luer Connector | LHI | 2018-06-07 |
| 53583 | 1792002113 | K131979 | PROVANT THERAPY SYSTEM | ILX | 2013-12-13 |
| 119097 | 1163020400 | K122122 | REGEN SPRAY APPLICATOR, | FMF | 2012-11-09 |
| 164668 | 1012423311 | BK210661 | |||
| 164668 | 1178928953 | BK120066 | |||
| 119097 | 1178928953 | BK120066 | |||
| 164668 | 1029727989 | BK120057 | |||
| 119097 | 1029727989 | BK120057 | |||
| 119097 | 1053063911 | BK110061 | |||
| 164668 | 1053063911 | BK110061 | |||
| 164668 | 1983540782 | BK090048 | |||
| 119097 | 1983540782 | BK090048 | |||
| 193526 | 1064394591 | ||||
| 193526 | 1144970169 | ||||
| 194237 | 1221351444 | ||||
| 243886 | 1303725733 | ||||
| 193526 | 1342973042 | ||||
| 193526 | 1363605498 | ||||
| 139902 | 1514956349 | ||||
| 160543 | 1628587076 | ||||
| 66302 | 1633003452 | ||||
| 193526 | 1641059208 | ||||
| 193526 | 1857428503 | ||||
| 193526 | 1860869929 | ||||
| 178703 | 1877443630 | ||||
| 193526 | 1891236281 | ||||
| 139902 | 2013035314 | ||||
| 119097 | 1012423311 | ||||
| 164668 | 1082805746 | ||||
| 194237 | 1168660404 | ||||
| 66302 | 1199015165 | ||||
| 290192 | 1203409999 | ||||
| 194237 | 1253941894 | ||||
| 66682 | 1303737482 | ||||
| 66302 | 1378419276 | ||||
| 194237 | 1392689326 | ||||
| 66302 | 1442581031 | ||||
| 292145 | 1591495551 | ||||
| 78029 | 1686904406 | ||||
| 66302 | 1729309331 | ||||
| 327508 | 1764907444 | ||||
| 119097 | 1765109681 | ||||
| 150904 | 1772305023 | ||||
| 292145 | 1821843796 | ||||
| 164668 | 1849072086 | ||||
| 119097 | 1849072086 | ||||
| 164668 | 1955429822 | ||||
| 119097 | 1955429822 | ||||
| 66302 | 1974899182 |
Product Codes Associated With Registrations#
NDC#
EYLEA
aflibercept
LIBTAYO
cemiplimab-rwlc
Evkeeza
evinacumab
Evkeeza
evinacumab
VEOPOZ
Pozelimab
Inmazeb
atoltivimab, maftivimab, and odesivimab-ebgn
Inmazeb
atoltivimab, maftivimab, and odesivimab-ebgn
Praluent
alirocumab
Praluent
alirocumab
EYLEA HD
aflibercept
EYLEA HD
aflibercept
LYNOZYFIC
linvoseltamab-gcpt
LYNOZYFIC
linvoseltamab-gcpt
OTARMENI
lunsotogene parvec
Regener-Eyes
Regener-Eyes
Regener-Eyes
Glycerin
Xcellderma
Wound Cream
Recuren Plus Antifungal Cream
Miconazole Nitrate 2%
Recuren Plus Arnica Bruise Cream
Arnica Montana 7%
Recuren Plus Jock Itch Cream
Miconazole Nitrate 2%
Recuren Plus Face Cream
Salicylic Acid 0.5%, Zinc Pyrithione 0.25%
Recuren Plus Balanced Scalp
Salicylic Acid
PMN#
REGER Nebulizer Irrigation Cannula
Reger Medizintechnik, GmbH
Reprieve by RegenesisTM
Regenesis Biomedical, Inc.
Peripheral Blood Processing Device For Wound Management
RegenLab SA
KEGEL SMART, KEGELSMART PEARL
REGULATORY INSIGHT, INC.
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
REGULATORY TECHNOLOGY SERVICES, LLC
VTI SUCTION IRRIGATION SYSTEM
REGULATORY TECHNOLOGY SERVICES, LLC
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
RegenLab SA
PROVANT THERAPY SYSTEM
REGENESIS BIOMEDICAL, INC.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
RegenLab SA
REGEN SPRAY APPLICATOR,
REGEN LAB SA
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
RegenLab SA
ETHEREA
REGULATORY INSIGHT, INC.
THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
REGULATORY SPECIALISTS, INC.
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
REGULATORY AND MARKETING SERVICES, INC.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
RegenLab SA
PROVANT SYSTEM, MODEL 4201
REGENESIS BIOMEDICAL, INC.
REGEN COLLAGEN SCAFFOLD (CS)
REGEN BIOLOGICS, INC.
REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
REGENERATION TECHNOLOGIES, INC.
BIOSET XCH
REGENERATION TECHNOLOGIES, INC.
CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
REGENERATION TECHNOLOGIES, INC.
STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937
REGENERATION TECHNOLOGIES, INC.
INTERSON USB ULTRASOUND PROBE SYSTEM
REGULATORY MANAGEMENT SERVICES
BIOSET XC
REGENERATION TECHNOLOGIES, INC.
BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC
BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
REGENT MEDICAL AMERICAS, LLC
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
REGENERATION TECHNOLOGIES, INC.
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC
STERLING INTERFERENC SCREW HT
REGENERATION TECHNOLOGIES, INC.
STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES
REGENERATION TECHNOLOGIES, INC.
BIOGEL LATEX STERILE POWDER-FREE GLOVE
REGENT MEDICAL AMERICAS, LLC
STERLING INTERFERENCE SCREW ST
REGENERATION TECHNOLOGIES, INC.
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
REGENT MEDICAL AMERICAS, LLC
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
REGENERATION TECHNOLOGIES, INC.
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
REGENERATION TECHNOLOGIES, INC.
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS
REGULATORY INSIGHT, INC.
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS
REGULATORY INSIGHT, INC.
RETINADX
REGULATORY ASSOCIATES, INC.
REGENESIS MODEL 42
REGENESIS BIOMEDICAL, INC.
MODEL ME 300 MUSCLE TESTER
REGULATORY STRATEGIES, INC.