FDA.reportPublic FDA data

PARAGON MEDICAL, INC.

Matched from indexed company URL: Paragon Medical Inc.

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
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
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
30114453593011445359Paragon Medical - Southington1N2026-01-0175 Aircraft Road Southington CT US 06489

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
00857387006237Stryker Universal Select Sterilization Tray System - 1.7 Mid-Face Plates Module1-800-225-6975info@paragonmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
996761269807361P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
996761335853972K990214FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEMHAW1999-04-22
996761308180569K983670STEALTHSTATION SYSTEMHAW1999-01-14
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
996762014025982K941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORLXT1994-10-03
996761331660731K934765TRILOGY ACETABULAR SYSTEMLPH1994-04-29
1804471055621049K874062ENTERON LIVER BIOPSY TRAYKNW1987-12-31
1804471458967138K874036MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRYCCK1987-11-06
494531920083032K190667Sonopet iQ Sterilization TrayKCT2019-06-13
494531291309796K183701Stryker ChestShield Sterilization Tray SystemKCT2019-05-07
996761942376713K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionOLO2018-11-02
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
996761223036001K171045Exactech® Truliant™ Line ExtensionsJWH2017-04-28
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
1428761825062831K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM2017-08-17
996761225080470K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemHSB2017-01-24
1428761022206076K153502ClariVein ICKRA2016-01-06
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
1804471126171798K143299Percuvance(R) Percutaneous Surgical SystemGCJ2015-01-21
996761838859641K141992VARIAX 2 SYSTEMHRS2014-08-07
996761995815038K141760ORTHOFIX GALAXY WRISTKTT2014-12-08
996761976715886K141571ORTHOFIX ANKLE HINDFOOT NAILING SYSTEMHSB2014-11-12
996761865019837K131425NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTEROLO2013-08-14
996761781146907K124004NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPSOLO2013-03-22
996761673540630K113369ZIMMER PERSONA KNEE SYSTEMJWH2012-03-27
996761617852079K110145BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHORMBI2011-03-04
996761821717289K103404ANA0TOMICAL SHOULDER TM COMBINED SYSTEMKWT2011-03-15
494531271046384K093853SINGLE-PATIENT USE DISPOSABLE SENSOR SERIESDQA2010-06-04
996761298629813K093293VANGUARD 360 REVISION KNEE SYSTEMJWH2010-10-22
494531622510544K091614OSTEOMED FOOT PLATING SYSTEMHRS2009-09-10
1428761166354325K071468CLARIVEIN CATHETERKRA2008-03-20
996761943521954K050651MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATIONHAW2005-07-27
996761300378980K050438STEALTHSTATION SYSTEM UPDATEHAW2005-06-02
1428761474147212K032387TRIVEX SYSTEMDWQ2003-10-29
996761573184452K022126CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEMHAW2003-01-03
996761287660430K012937KNEE MODULE FOR THE STEALTHSTATION SYSTEMHAW2002-01-25
996761006649929
996761166652912
996761210720333
1524081211756174
996761230518398
996761234076054
1804471246779700
996761299551307
996761301317428
996761320845491
996761339535350
996761400538499
996761407487889
996761411384969
996761426008522
996761488166524
1804471540123864
996761569735281
996761695622246
996761988863442
494531994789061
996762035995877
996762047145031
494531002270931
494541002270931
996761002270931
1466061002270931
494531004862608
494531006649929
1466061006649929
1428761008550624
494531009686523
996761010075295
494531013795114
494531014227314
1466061023847167
1524081037616399
1524081038163123
1524081040031071
494531042758975
1466061043889624
494531047247420
1466061050498582
494531050850811
1524081051238230
1524081052304061
494541053130165
494531054976693
1524081060251225
1466061064341795
1428761069029674
1524081073055615
494531077345977
494531078134058
996761078134058
494531085798643
494541085798643
996761085798643
996761089897765
494531093050146
494531095142475
996761095787975
1428761103774440
1466061105652706
1428761107480407
1466061111361710
1466061113385961
1524081114865967
494531117910207
494531118190292
1466061118190292
494531125431158
494531131389403

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HAW102005-07-27
KCT42019-06-13
OLO32018-11-02
HSB32018-04-23
KTT32017-05-10
JWH32017-04-28
HRS32015-10-27
KRA22016-01-06
OBT12018-01-09
HTY12017-11-16
DWM12017-08-17
NKB12017-05-11
GEI12016-04-08
GCJ12015-01-21
KWT12011-03-15
MBI12011-03-04
DQA12010-06-04
DWQ12003-10-29
LXT11994-10-03
LPH11994-04-29
KNW11987-12-31
CCK11987-11-06
NJL11985-04-12

PMN#

GUDID#

56 records. Showing 1-40. Next