FDA.reportPublic FDA data

PARAGON

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18343311000306340PARAGON MEDICAL, INC.1N2026-01-018 Matchett Dr. PIERCETON IN US 46562
18358313001814066Paragon Medical Inc.1N2026-01-017350 E. 86TH ST. Castleton IN US 46256
10001360421000136042Paragon Packaging Incorporated1N2026-01-01200 Fairway Lane Old Bridge NJ US 08857
10002009891000200989Paragon Medical - Dayton1N2026-01-014201 Little York Rd Dayton OH US 45414
10005174061000517406Paragon Medical Inc.1N2026-01-01125 W 1000 S Smithfield UT US 84335
30054098993005409899PARAGON IMPLANT MFG., LLC1N2026-01-0127030 Malibu Hills Rd Calabasas CA US 91301
30075394893007539489Paragon Medical Device (Changzhou) Co., Ltd.1N2026-01-013A GDH Industrial Park No. 16 Chuangye Road Changzhou Jiangsu CN 213033
30075446343007544634Paragon Medical - Mansfield, Bridgemedica1N2026-01-01111 Forbes Blvd Suite 101 Mansfield MA US 02048
30086501173008650117PARAGON 281N2026-01-0114445 Grasslands Dr. Englewood CO US 80112
30111755553011175555PARAGONIX TECHNOLOGIES, INC.1Y2026-01-01950 Winter Street, North Waltham MA US 02451
30114453593011445359Paragon Medical - Southington1N2026-01-0175 Aircraft Road Southington CT US 06489
30133989573013398957Paragon Vision Sciences, Inc.1Y2026-01-012120 W. Guadalupe Rd. Gilbert AZ US 85233
30337088183033708818PARAGON IMPLANT COMPANY, LLC1N2026-01-018840 W Russell Rd Ste 200 Las Vegas NV US 89148
20204332020433Paragon Vision Sciences1Y2020-04-25947 E Impala Ave MESA AZ US 85204
30155451163015545116PARAGON SURGICAL LLC1N2020-04-251213 Live Oak Ct United States Ft Collins CO US 80525

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2145271412931014P870024FLUOROPERM RGP CONTACT LENSESMWL1987-12-31
2145331412931014P870024FLUOROPERM RGP CONTACT LENSESMWL1987-12-31
996761269807361P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
2145271270175832P820063
2145331270175832P820063
2145271259636437P050031PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPYNUU2006-11-16
2145331259636437P050031PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPYNUU2006-11-16
1579791470782190K992081VARIOUS ANSELL TRADENAMES OR PRIVATE LABELHIS1999-08-19
996761335853972K990214FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEMHAW1999-04-22
996761308180569K983670STEALTHSTATION SYSTEMHAW1999-01-14
1579791306302599K983518LIFESTYLES XTRA PLEASUREHIS1999-07-06
1199831077493669K981386MANAN BLUNT NEEDLEFPA1998-06-29
996761095787975K974187STEALTHSTATION SYSTEMHAW1998-01-21
996761795556349K972398STEALTHSTATION PASSIVE INSTRUMENT OPTIONHAW1997-09-16
996761682857399K971247SNT DISPOSABLE BIOPSY NEEDLEHAW1997-06-16
996761010075295K954276STEALTHSTATIONHAW1996-01-24
996761321441422K953406EBI X FIX DYNAFIX SYSTEM (DFS)KTT1995-10-31
1579791568701065K942858LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)HIS1995-05-18
1579791164924489K941258LATEX CONDOMHIS1995-12-06
996762014025982K941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORLXT1994-10-03
2145331662601283K940277PAFLUFOCON A, B, C & DHQD1994-05-09
996761331660731K934765TRILOGY ACETABULAR SYSTEMLPH1994-04-29
1579791551742889K931077LATEX PROPHYLACTIC RUBBER CONTRACEPTIVEHIS1994-09-14
1579791250119875K893039CONDOM (RUBBER) CONTRACEPTIVEHIS1990-05-04
1804471055621049K874062ENTERON LIVER BIOPSY TRAYKNW1987-12-31
1804471458967138K874036MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRYCCK1987-11-06
1199832004370429K253886Grappler Suture Anchor PCFD Tether SystemMBI2026-03-17
1199831483655718K253613Monkey Rings External Ring Fixation SystemKTT2025-12-19
1199831911374121K253591Phantom® Hindfoot TTC/TC Nail SystemHSB2026-03-05
3314891036565517K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsDZE2025-12-23
3327871223629795K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsDZE2025-12-23
1199831945379636K252106External Fixation Mini Rail SystemKTT2025-09-30
3327871378265528K251938GEN5 and GEN5+ Dental Implant SystemDZE2025-10-30
3314891714135322K251938GEN5 and GEN5+ Dental Implant SystemDZE2025-10-30
1199831637577992K251862External Fixation Bone DistractorKTT2025-08-11
1199831246847802K251850Phantom® Hindfoot TTC/TC Nail SystemHSB2025-07-14
3327871483950267K251756Sterilization TraysKCT2025-11-14
3314891666229434K251756Sterilization TraysKCT2025-11-14
1199831203920332K250952Baby Gorilla®/Gorilla® Plating SystemHRS2025-07-18
1199831677573124K250641APEX 3D Total Ankle Replacement SystemHSN2025-05-01
3327871192948775K250476NizPlant Dental Implant SystemDZE2025-12-23
3314892053138823K250476NizPlant Dental Implant SystemDZE2025-12-23
1199831267190117K242452Monkey Bars Pin to Bar External Fixation SystemKTT2024-11-01
1199831182844441K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemHRS2024-06-05
1199831817348340K240594Grappler Suture Anchor R3FLEX IOL SystemMBI2024-03-26
1199831076545538K240259APEX 3D Total Ankle Replacement SystemHSN2024-06-24
1199831522940115K234128Phantom Fibula Nail SystemHSB2024-08-22
2178641823589963K234060KIDNEYvault Portable Renal Perfusion SystemKDN2024-10-23
1199831955472953K232838Monkey RingsTM External Fixation SystemKTT2023-10-12
1199831057399452K231867Grappler Suture Anchor SystemMBI2023-08-21
1199831078558746K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation DevicesHWC2023-10-12
1199831204024276K230550JAWS Nitinol Staple SystemJDR2023-05-11
2178641933045634K223874BAROguardKDN2023-08-15
1199831640640986K223184Phantom Metatarsal Shortening SystemHWC2022-12-16
1199831166340662K222194Baby Gorilla®/Gorilla® Plating SystemHRS2022-08-19
1199831504467427K222091Grappler Suture Anchor SystemMBI2022-09-14
2145271524170443K221768Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesHQD2023-05-05
1199831386342824K221465Baby Gorilla/Gorilla Plating SystemHRS2022-06-17
1199831084737294K212895Paragon 28 External Ring Fixation SystemKTT2021-11-08
1199831302624798K211770R3ACT Stabilization SystemHWC2021-12-25
1199831721438921K211322Paratrooper Plantar Plate Repair SystemMBI2021-08-30
1199831111383830K211112OIC External Fixation SystemKTT2021-05-05
1199832039216340K211076Patient Specific Marking GuidesPBF2022-06-28
1199831582959418K211002Grappler Suture Anchor SystemMBI2021-07-07
1199832038979358K210869Phantom Hindfoot TTC/TC Nail SystemHSB2021-06-28
1199832049780961K210390Apex 3D Total Ankle Replacement SystemHSN2021-03-06
1199831695331858K203511Baby Gorilla/Gorilla Plating SystemHRS2020-12-29
1199831650980121K203385TenoTac Soft Tissue Fixation SystemMBI2021-02-11
1199831971094352K203011Monster Screw SystemHWC2020-11-13
1199831139538852K202019Maven Patient-Specific InstrumentationHSN2021-01-14
1199831240723450K201227Phantom® Hindfoot TTC/TC Nail SystemHSB2020-07-17
1199831865929666K200513DAC Dynamic Active Compression PlateHRS2020-07-22
1199831757547833K192994Paragon 28 APEX 3D Total Ankle Replacement SystemHSN2020-07-10
2178641761125737K192869SherpaPak Lung Preservation System , SherpaPak Liver Transport SystemKDN2020-01-16
1199831858929712K192674Mixing and Delivery SystemFMF2020-02-18
1199831553372203K192163TTC Phantom® Intramedullary Nail SystemHSB2020-01-31
1199831361265782K191782TTC Phantom Intramedullary Nail SystemHSB2019-09-06
2178642024431391K191440Paragonix SherpaPak Pancreas Transport SystemKDN2019-12-20
1199831213480138K191227Paratrooper Plantar Plate Repair SystemMBI2020-01-24
494531920083032K190667Sonopet iQ Sterilization TrayKCT2019-06-13
1199831970611724K190586Monster® Screw SystemHWC2019-04-03
1199831112536265K190365Baby Gorilla/Gorilla Plating SystemHRS2019-04-12
494531291309796K183701Stryker ChestShield Sterilization Tray SystemKCT2019-05-07
1199831494124798K183690Tenodesis Screw SystemMBI2019-03-01
1199831665646234K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesHRS2019-01-10
1199831360014085K182898TenoTac Soft Tissue Fixation SystemMBI2019-01-14
1579791022925223K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesMOL2018-12-06
1199831763781214K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemHSB2019-01-14
996761942376713K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionOLO2018-11-02
1199831731280891K180239Additive Orthopaedics Patient Specific 3D Printed Bone SegmentsHRS2018-05-16
2178641293869649K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemMSB2018-03-30
2145271739227670K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEGHQD2018-03-16
494532006915165K173615Stryker Universal Select Sterilization Tray SystemKCT2018-04-18
996761450550919K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILHTY2017-11-16
996761187759029K172699Agile NailHSB2018-04-23
996761078134058K172183Guided Growth Plate System PlusOBT2018-01-09
1199831201980552K171715HammerTube SystemHTY2018-03-05
1579791976497721K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL2017-08-02
996761223036001K171045Exactech® Truliant™ Line ExtensionsJWH2017-04-28
1199832011015693K170923JAWS(TM) Nitinol Staple SystemJDR2017-07-24
1199832035390843K170693Phantom Small Bone Intramedullary Nail SystemKTW2017-06-19
996761905768568K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® SystemsNKB2017-05-11
996761823923480K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0KTT2017-05-10
1199831507889962K170214Additive Orthopaedics Locking Lattice PlateHRS2017-04-13
1199831810425511K163593Additive Orthopaedics Bunion SystemHRS2017-06-20
1428761825062831K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM2017-08-17
1579791974314025K163107Lifestyles Zero Lubricated Latex Male CondomHIS2017-01-23
1199831285114866K162241TITAN 3-D™ Wedge SystemPLF2017-04-03
996761225080470K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemHSB2017-01-24
1579791284661479K160399Skyn Original Polyisoprene Lubricated Male CondomMOL2016-07-25
1199832071510035K160264Additive Orthopaedics Hammertoe Correction SystemHTY2016-06-01
1428761022206076K153502ClariVein ICKRA2016-01-06
1199831055872716K153207Additive Orthopaedics Bone Wedge SystemHRS2016-09-07
1804471103905665K153063PERCUVANCE PERCUTANEOUS SURGICAL SYSTEMGEI2016-04-08
494531142138815K152951Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization TrayKCT2015-12-28
996761903875433K151769Anchorage 2 CP SystemHRS2015-10-27
1199831819319623K151418Monster Screw SystemHWC2015-07-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS152025-07-18
HIS142017-01-23
MBI122026-03-17
HSB112026-03-05
KTT102025-12-19
HAW102005-07-27
HWC82023-10-12
HQD72023-05-05
DZE62025-12-23
KCT62025-11-14
HSN52025-05-01
KDN42024-10-23
MOL42018-12-06
OLO32018-11-02
HTY32018-03-05
JWH32017-04-28
HEB32013-03-21
JDR22023-05-11
KRA22016-01-06
MQV22015-08-18
NUU22006-11-16
MUW22001-02-28
MWL21987-12-31
PBF12022-06-28
FMF12020-02-18
MSB12018-03-30
OBT12018-01-09
DWM12017-08-17
KTW12017-06-19
NKB12017-05-11
PLF12017-04-03
GEI12016-04-08
GCJ12015-01-21
MBP12013-05-31
KWT12011-03-15
DQA12010-06-04
FRO12005-06-13
DWQ12003-10-29
LRX12003-06-12
FPA11998-06-29

NDC#

PMA#

179 records. Showing 1-40. Next

PMN#

113 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next