Gordon Macfarlane

FDA Filings

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

FDA Registration(s)
Registration Number3013143953
FEI Number3013143953
NameGordon MacFarlane
Owner & OperatorActim Oy
Contact AddressKlovinpellontie 3
Espoo FI-ES Etela-Suomen laani FI-02180 FI
Official Correspondent
  • Elina Carlson
  • 358-9-547680-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment TypeManufacture Medical Device

Registration Number3011453824
FEI Number3011453824
NameGordon MacFarlane
Owner & OperatorTheratechnologies Inc.
Contact Address2015 Peel Street, Suite 1100
Montreal CA-QC Quebec H3A1T8 CA
Official Correspondent
  • Kenza Laassel
  • 1-438-3156633-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Parkway
North Wales, PA 19454 US
Establishment TypeRepack or Relabel Medical Device

Registration Number3010872792
FEI Number3010872792
NameGordon MacFarlane
Owner & OperatorPerouse Medical
Contact AddressROUTE DU MANOIR
IVRY-LE-TEMPLE FR-60 Oise 60173 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number1000212994
FEI Number1000212994
NameGordon MacFarlane
Owner & OperatorActim Oy
Contact AddressKlovinpellontie 3
Espoo FI-ES Etela-Suomen laani FI-02180 FI
Official Correspondent
  • Elina Carlson
  • 358-9-547680-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment TypeManufacture Medical Device

Registration Number3012404688
FEI Number3012404688
NameGordon MacFarlane
Owner & OperatorSynetik ErgoCare
Contact Address1242 De Lanaudiere
Joliette CA-QC Quebec J6E 3P1 CA
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment TypeManufacture Medical Device

Registration Number3004160911
FEI Number3004160911
NameGordon MacFarlane
Owner & OperatorPerouse Medical
Contact AddressRoute du Manoir --
IVRY-LE-TEMPLE FR-60 Oise 60173 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3011224555
FEI Number3011224555
NameGordon MacFarlane
Owner & OperatorSYMATESE DEVICE
Contact Address135 Route Neuve
IRIGNY FR-69 Rhone 69540 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

Registration Number3006942524
FEI Number3006942524
NameGordon MacFarlane
Owner & OperatorPerouse Medical
Contact AddressRoute du Manoir
IVRY-LE-TEMPLE FR-60 Oise 60173 FR
US Agent
Importing Logistics Registration
ImporterARROW International
Address2400 Bernville Road
Reading, PA 19605 UNITED STATES
Phone1 800 5238446
FAX1 610 3780131
Importer TypeRetailer
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3009749507
FEI Number3009749507
NameGordon MacFarlane
Owner & OperatorInnovative Trauma Care Inc
Contact Address914 Jordan Crescent
Edmonton CA-AB Alberta T6L 6X5 CA
Official Correspondent
  • Kelly Mottet
  • 1-780-2334294-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

Registration Number3005622096
FEI Number3005622096
NameGordon MacFarlane
Owner & OperatorOTSUKA PHARMACEUTICAL CO., LTD.
Contact AddressSHINAGAWA GRAND CENTRAL TOWER 2-16-4 KONAN, MINATO-KU
TOKYO JP-13 Tokyo 108-8242 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment TypeManufacture Medical Device

Registration Number3010358810
FEI Number3010358810
NameGordon MacFarlane
Owner & OperatoreSight Corp.
Contact Address515 Legget Drive Suite 200
Ottawa CA-ON Ontario K2K3G4 CA
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Gordon MacFarlane [Theratechnologies Inc.]
Injection box of EGRIFTA 1 mg/vial2020-03-17
Gordon MacFarlane [Theratechnologies Inc.]
Injection box of EGRIFTA SV 2 mg/vial2020-03-17
Gordon MacFarlane [Theratechnologies Inc.]
Injection box of EGRIFTA SV 2 mg/vial2020-03-17
Gordon MacFarlane [Theratechnologies Inc.]
Injection box of EGRIFTA 1 mg/vial2020-03-17
Gordon MacFarlane [Theratechnologies Inc.]
Injection Box for EGRIFTA 1 mg/vial2020-03-05
Gordon MacFarlane [Theratechnologies Inc.]
Injection Box for EGRIFTA 1 mg/vial2020-03-05
Gordon MacFarlane [SYMATESE DEVICE]
DOLPHIN Inflation Device2018-08-10
Gordon MacFarlane [SYMATESE DEVICE]
Traumacem V+ Syringe Kit2017-09-26
Gordon MacFarlane [Perouse Medical]
Dolphin Inflation Device2017-01-11
Gordon MacFarlane [Synetik ErgoCare]
Control Mounts, Support Hooks (Tube Frame 1")2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Tray Supports and Hardware2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Side Thoracic Supports2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Side Thoracic Supports and Brackets2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Hardware and Anchoring2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Cephalic Control Supports2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Cephalic Control Supports: Accessories and Hardware2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Backrest Accessories with Straps2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Anchorage and Hardware2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Abductor Support Brackets2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Belts, Standard Shoulder Harness, Ankle Positioning Straps2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Stander Elite2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Positioning Seat2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Headrest, Headrest Mounts, Headrest Anchorage Mechanisms2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Cubic Gel Pads, Cellular Gel Pads2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Lower Limb Accessories2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Armrest Support, Upper Limb Accessories2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Compact Anthropometric Ruler2016-06-15
Gordon MacFarlane [Synetik ErgoCare]
Stander Baby, Stander Kid, Stander Junior, Stander Hybrid, Stander Elite2016-05-23
Gordon MacFarlane [SYMATESE DEVICE]
D750b Guiding Kit - Mammotome2016-03-21
Gordon MacFarlane [SYMATESE DEVICE]
D750b Guiding Kit - Hologic2016-03-21
Gordon MacFarlane [SYMATESE DEVICE]
D750b Guiding Kit - BARD 7G2016-03-21
Gordon MacFarlane [SYMATESE DEVICE]
D750b Guiding Kit - BARD 10G2016-03-21
Gordon MacFarlane [Innovative Trauma Care Inc]
iTClamp2015-07-03
Gordon MacFarlane [Perouse Medical]
Inflation System2015-04-01
Gordon MacFarlane [Perouse Medical]
Inflation System2015-04-01
Gordon MacFarlane [Perouse Medical]
Flamingo Inflation Device2015-02-02
Gordon MacFarlane [SYMATESE DEVICE]
Vertecem V + Syringe kit2014-12-01
Gordon MacFarlane [Actim Oy]
Actim PROM2014-11-28
Gordon MacFarlane [Actim Oy]
Actim PROM2014-11-28
Gordon MacFarlane [Actim Oy]
Actim PROM Controls2014-11-28
Gordon MacFarlane [Actim Oy]
Actim PROM Controls2014-11-28
Gordon MacFarlane [Perouse Medical]
Flamingo Inflation Device2014-11-18
Gordon MacFarlane [Perouse Medical]
SEAL ONE? Radial Compression Device2014-11-13
Gordon MacFarlane [Perouse Medical]
MyShell Lite2014-11-13
Gordon MacFarlane [Perouse Medical]
Dolphin Inflation Device2014-11-13
Gordon MacFarlane [Perouse Medical]
POLYPERF without injection site2014-08-01
Gordon MacFarlane [Perouse Medical]
POLYPERF with injection site2014-08-01
Gordon MacFarlane [Perouse Medical]
POLYPERF SAFE without injection site2014-08-01
Gordon MacFarlane [Perouse Medical]
POLYPERF SAFE with injection site2014-08-01
Gordon MacFarlane [Perouse Medical]
POLYPERF without injection site2014-08-01
Gordon MacFarlane [Perouse Medical]
POLYPERF with injection site2014-08-01
Gordon MacFarlane [Perouse Medical]
POLYPERF SAFE without injection site2014-08-01
Gordon MacFarlane [Perouse Medical]
POLYPERF SAFE with injection site2014-08-01
Gordon MacFarlane [Perouse Medical]
PPS PI? Pressure Injectable Safety Huber Needle2014-04-24
Gordon MacFarlane [Perouse Medical]
PPS PI? Pressure Injectable Safety Huber Needle2014-04-24
Gordon MacFarlane [Perouse Medical]
POLYSITE Implantable Infusion Port2013-12-17
Gordon MacFarlane [Perouse Medical]
POLYSITE Implantable Infusion Port2013-12-17
Gordon MacFarlane [Perouse Medical]
SEAL ONE? Radial Compression Device2013-01-30
Gordon MacFarlane [Perouse Medical]
PPS PI? Pressure Injectable Safety Huber Needle2013-01-30
Gordon MacFarlane [Perouse Medical]
PPS PI? Pressure Injectable Safety Huber Needle2013-01-30
Gordon MacFarlane [Perouse Medical]
STERILE NEEDLE GUIDE2010-04-19
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
POC-AS10 Auto sampler2010-03-14
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
POC-AS10 Auto sampler2010-03-14
Gordon MacFarlane [Perouse Medical]
MyShell Lite2008-09-11
Gordon MacFarlane [Perouse Medical]
Dolphin Inflation Device2008-09-11
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
POCone Spectrophotometer2008-04-24
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
POCone Spectrophotometer2008-04-24
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
UBiT-IR300 Spectrophotometer2008-04-24
Gordon MacFarlane [Perouse Medical]
POLYPERF2008-02-05
Gordon MacFarlane [Perouse Medical]
POLYPERF Safe2008-02-05
Gordon MacFarlane [Perouse Medical]
POLYPERF2008-02-05
Gordon MacFarlane [Perouse Medical]
POLYPERF Safe2008-02-05

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