Elaine Duncan

FDA Filings

This page includes the latest FDA filings for Elaine Duncan. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004859928
FEI Number3004859928
NameElaine Duncan
Owner & OperatorProxy Biomedical Ltd
Contact AddressCoilleach Spiddal
Co. Galway IE-NOTA H91 C2NF IE
Official Correspondent
  • Adrienne Tierney
  • 353-91-896900-934
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 Valley View Trail
Houlton, WI 54082 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3012075008
FEI Number3012075008
NameElaine Duncan
Owner & OperatorSynaptive Medical Inc
Contact Address555 Richmond St West, Suite 800
Toronto CA-ON Ontario M5V 3B1 CA
Official Correspondent
  • Maham Ansari
  • 1-844-4627246-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 Valley View Trl
Houlton, WI 54082 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

Registration Number3003756985
FEI Number3003756985
NameElaine Duncan
Owner & OperatorASP PLASTICS PTY LTD.
Contact Address17 HARRIS ST. --
ST-MARYS NSW AU-NOTA 2760 AU
Official Correspondent
  • Meredyth - Love
  • 61-2-88819-460
US Agent
Importing Logistics Registration
ImporterSafety Works
Address118N. Bedford Road Suite 100
Mount Kisco, NY 10549 UNITED STATES
Phone1 914 6983631
FAX1 914 3811341
Importing Logistics Registration
ImporterTotal Access Group
Address1671 E. Saint ndrew Place
Santa Ana, CA 92705 UNITED STATES
Phone1 714 2599400 218
FAX1 714 2599202
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 Valley View Trail
Houlton, WI 54082 US
Establishment TypeRepack or Relabel Medical Device

Registration Number3008506949
FEI Number3008506949
NameELAINE DUNCAN
Owner & OperatorCERACARTA SPA
Contact AddressSecondo Casadei,14
Forli IT-FO Forli 47122 IT
Official Correspondent
  • Francesca Tanfi
  • 039-0543-780055-x
US Agent
Importing Logistics Registration
ImporterS&W HEALTHCARE CORPORATION
Address15251 FLIGHT PATH DRIVE
Brooksville, FL 34604 UNITED STATES
Email Addressrj@swhealthcare.com
Phone1 352 7997477
FAX1 352 7997637
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 VALLEY VIEW TRAIL
Houlton, WI 54082 US
Establishment TypeManufacture Medical Device

Registration Number3016250463
FEI Number3016250463
NameElaine Duncan
Owner & OperatorAlphaMet Ltd.
Contact Address3 Hadolev st.
Bar-Lev High-Tech Park IL-NOTA 2015600 IL
Official Correspondent
  • Rafi Herzog
  • 972-5-8769250-x
US Agent
Importing Logistics Registration
ImporterGenesis Ortho Partners
Address307 S. 2nd st.
Garrett, IN 46738 UNITED STATES
Email AddressBcoburn@genorthopartners.com
Phone1 260 4382198
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 Valley View Trail
Houlton, WI 54082 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

Registration Number3011861727
FEI Number3011861727
NameElaine Duncan
Owner & OperatorMESI D.O.O.
Contact AddressLeskoskova 11a
Ljubljana SI-061 Ljubljana (urbane commune) 1000 SI
Official Correspondent
  • Jakob Susteric
  • 386-1-6203487-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 Valley View Trail
Houlton, WI 54082 US
Establishment TypeManufacture Medical Device

Registration Number3004176895
FEI Number3004176895
NameElaine Duncan
Owner & OperatorBK MEDITECH CO., LTD.
Contact Address58, Eunhaengnamu-ro, Yanggam-myeon --
Hwaseong-si KR-41 Gyeonggido 18633 KR
Official Correspondent
  • BYOUNGJUN - PARK
  • 82-31-3529135-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 Valley View Trail
Houlton, WI 54082 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Elaine Duncan [AlphaMet Ltd.]
CyclaPlex Correction System2019-12-16
Elaine Duncan [Synaptive Medical Inc]
Modus Nav2019-10-04
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA PLUS SPINE SYSTEM2019-09-20
Elaine Duncan [MESI D.O.O.]
ABPI MD2018-12-18
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA PLUS SPINE SYSTEM2018-03-18
Elaine Duncan [Synaptive Medical Inc]
Modus Plan2018-03-16
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Plan 1.62018-03-16
Elaine Duncan [Synaptive Medical Inc]
Fiducial Markers2017-09-27
Elaine Duncan [MESI D.O.O.]
TM-ABI SYSTEM2017-06-22
Elaine Duncan [MESI D.O.O.]
MESI ABPI MD2017-06-22
Elaine Duncan [Synaptive Medical Inc]
Sony LMD-X550MT 4K 3D/2D Surgical Monitor2017-06-14
Elaine Duncan [Synaptive Medical Inc]
Sony LMD-X550MD 4K Surgical Monitor2017-06-14
Elaine Duncan [Synaptive Medical Inc]
Anisotropic Diffusion Phantom2017-01-06
Elaine Duncan [Synaptive Medical Inc]
Synaptive Trackable Suction2016-10-21
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Pointer with BrightMatter Guide2016-08-22
Elaine Duncan [Synaptive Medical Inc]
Barco MDSC-82322016-08-22
Elaine Duncan [Synaptive Medical Inc]
ImageDrive Clinical2016-07-04
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Guide with SurfaceTrace2016-07-04
Elaine Duncan [Synaptive Medical Inc]
Patch drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Monitor drape sheet2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Floating estop drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Drive skirt drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Cranial reference drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Arm drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
3D Arm drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Navigation System2015-04-02
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Guide2015-04-02
Elaine Duncan [Synaptive Medical Inc]
NDI Passive Spheres2015-04-02
Elaine Duncan [BK MEDITECH CO., LTD.]
INNESIS PEEK TL CAGE2014-11-04
Elaine Duncan [BK MEDITECH CO., LTD.]
INNESIS PEEK CERVICAL CAGE2014-11-04
Elaine Duncan [BK MEDITECH CO., LTD.]
BALL CURETTE2014-11-04
Elaine Duncan [Synaptive Medical Inc]
Modus V2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Vision2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Pointer with Modus V2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Pointer with BrightMatter Drive2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Drive2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Planning2014-06-10
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Plan 1.02014-06-10
Elaine Duncan [Synaptive Medical Inc]
ClearCanvas RIS/PACS2014-05-15
Elaine Duncan [BK MEDITECH CO., LTD.]
WRENCH 3.0(3.0MM HEX)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
REDUCER T-WRENCH2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
PICK-UP WRENCH2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
PICK-UP WRENCH(5MM)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
PICK-UP WRENCH(4.5MM)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL WRENCH(BT30)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL WRENCH(BT20)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL WRENCH(5MM)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL WRENCH(4.5MM)2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
DUAL LOCKING WRENCH2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
DOUBLE STARTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
3.5MM FINAL TIGHTENER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
STRAIGHT IMPACTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
INSERTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
IMPACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
GRAFT INSERTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
GRAFT IMPACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
FINAL IMPACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
CURVED IMPACTER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
SHAVER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
RASP2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
ROOT RETRACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
DURA RETRACTOR2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
LONG-ARM BREAKER2013-11-17
Elaine Duncan [BK MEDITECH CO., LTD.]
SURGICAL INSTRUMENT TRAY2013-11-17
Elaine Duncan [Proxy Biomedical Ltd]
Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device2013-07-03
Elaine Duncan [Proxy Biomedical Ltd]
Colpassist Vaginal Positioning Device2013-05-02
Elaine Duncan [Proxy Biomedical Ltd]
Upsylon Traditional Y mesh2013-03-19
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA5.5 SPINE SYSTEM2013-03-13
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA5.5 SPINE SYSTEM2013-03-13
Elaine Duncan [BK MEDITECH CO., LTD.]
INNESIS PEEK CAGE2013-03-13
Elaine Duncan [BK MEDITECH CO., LTD.]
Dyna-EXTOR II External Fixation System2012-07-02
ELAINE DUNCAN [CERACARTA SPA]
ECO SUPERGEL2010-09-28
ELAINE DUNCAN [CERACARTA SPA]
ECO SUPERGEL CLEAR2010-09-28
ELAINE DUNCAN [CERACARTA SPA]
RECORDING PAPER AND RECORDING CHART PAPER2010-09-28
Elaine Duncan [BK MEDITECH CO., LTD.]
DVX5.5 SPINE SYSTEM2009-11-25
Elaine Duncan [BK MEDITECH CO., LTD.]
TRIAL2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
TESTER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
T-TYPE RATCHET HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SQ-ADAPTER HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SPINNER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SPANNER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SC REDUCER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROTATION TUBE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROTATION HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD GRIPPER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
RIGHT MARKER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
RELEASE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
REDUCTION INTRODUCER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
REDUCER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
REDUCER STICK2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
PERSUADER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MINI T-RATCHET HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
LEFT MARKER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
LARGE T-TORQUE HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
I-TYPE RATCHET HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
GUIDE PIN(R)2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
GUIDE PIN(L)2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
GRAFT CASE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
EXTRACTOR2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DISTRACTOR2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DISTRACTION SCREW2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DEROTATOR HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DEROTATION CLIP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
CLIP WRENCH2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
CAGE SUPPORT2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
BONE FILLER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
BALL POINT TESTER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ANTI TORQUE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ANTI TORQUE DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
4 SIDED I-RATCHET HANDLE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
TURNBUCKLE DRIVER-FIXED2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MULTI-AXIAL LONG-ARM SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MULTI SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MONO SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
LONG-ARM SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
INTERMEDIATE SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ILIAC SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DISTRACTION SCREW DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ALIGNMENT DRIVER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD BENDER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
FRENCH ROD BENDER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD ROCKER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD PUSHER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD INTRODUCER2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
ROD FORCEPS2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
POWER ROD FORCEPS2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
STRAIGHT PROBE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
STRAIGHT PROBE(LENKE)2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
BENT PROBE2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
BENT PROBE(LENKE)2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
9.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
8.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
7.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
7.0MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
6.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
6.0MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
5.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
5.0MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
4.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
3.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
10.5MM TAP2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
COMPRESSOR2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
AWL2008-07-02
Elaine Duncan [BK MEDITECH CO., LTD.]
DVX SPINE SYSTEM2008-07-01
Elaine Duncan [BK MEDITECH CO., LTD.]
DVX SPINE SYSTEM2008-07-01
Elaine Duncan [BK MEDITECH CO., LTD.]
HAKI Knife2008-04-29
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA SPINE SYSTEM2008-01-02
Elaine Duncan [BK MEDITECH CO., LTD.]
MEGA SPINE SYSTEM2008-01-02
Elaine Duncan [Proxy Biomedical Ltd]
Polyform Synthetic Mesh2007-11-29
Elaine Duncan [BK MEDITECH CO., LTD.]
PIN SCREW2006-07-26
Elaine Duncan [ASP PLASTICS PTY LTD.]
ASP Plastics Pty Ltd2004-06-01

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020060324208Yantian,China (Mainland) -> Oakland, CaliforniaSHAVE1 PCS
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