Ortho Surgical Products Enterprises S A

FDA Filings

This page includes the latest FDA filings for Ortho Surgical Products Enterprises S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010452421
FEI Number3010452421
NameOrtho and Surgical Products Enterprises S.A.
Owner & OperatorDEROYAL INDUSTRIES, INC.
Contact Address200 DEBUSK LN. --
Powell TN 37849 US
Official Correspondent
  • Elizabeth Reed
  • x-865-3621256-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressKM 20.5 Carretera a Villa Canales Zona 3 Finca Morancito,
Villa Canales Guatemala, 01065 GT
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Device, Transfer, Patient, Manual - DeRoyal2018-11-01
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Drape, Surgical, Exempt - DeRoyal2017-08-01
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
General Surgery Tray (Kit) - DeRoyal2016-06-03
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Dressing Change Tray - DeRoyal2015-12-10
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Burn Kit without Drug - DeRoyal2015-12-10
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Accessories, Traction - DeRoyal2015-09-21
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Exercise, Powered - DeRoyal2015-09-16
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Device, Intravascular Catheter Securement - DeRoyal2015-09-15
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Restraint, Protective - DeRoyal2015-09-15
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Accessories, Operating-Room, Table (Kit) - DeRoyal2012-09-28
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Aid, Transfer - DeRoyal2012-08-27
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Walker, Mechanical - DeRoyal2012-03-22
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Bed, Ac-Powered Adjustable Hospital - DeRoyal2011-07-14
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Crutch - DeRoyal2010-03-18
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Gauze/Sponge, Internal - DeRoyal2010-01-29
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Laparoscope, General & Plastic Surgery - DeRoyal2009-08-24
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Dressing, Wound, Drug - DeRoyal2007-12-28
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Container, Specimen, Non-Sterile - DeRoyal2006-08-22
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Instrument, Manual, Surgical, General Use - DeRoyal2006-08-22
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Component, Traction, Non-Invasive - DeRoyal2006-08-22
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal2006-08-22
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Marker, Skin - DeRoyal2006-08-22
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Fiber, Medical, Absorbent - DeRoyal2006-08-22
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Halter, Head, Traction - DeRoyal2006-08-09
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Bandage, Elastic - DeRoyal2006-08-09
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Splint, Clavicle - DeRoyal2006-07-27
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Sling, Arm - DeRoyal2006-07-27
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Protector, Skin Pressure - DeRoyal2006-07-27
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Joint, Knee, External Brace - DeRoyal2006-06-20
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Orthosis, Limb Brace - DeRoyal2006-06-20
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Orthosis, Lumbo-Sacral - DeRoyal2006-06-20
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
WRIST2006-06-20
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Splint, Hand, and Components - DeRoyal2006-06-20
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Binder, Abdominal - DeRoyal2006-06-20
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Catheter, Peritoneal - DeRoyal2005-10-25
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Tourniquet, Nonpneumatic - DeRoyal2005-09-28
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal2005-08-25
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Restraint, Wheelchair, Non-Protective - DeRoyal2005-08-08
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Joint, Ankle, External Brace - DeRoyal2005-08-08
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Support, Patient Position - DeRoyal2005-08-08
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Device, Fixation, Tracheal Tube - DeRoyal2005-08-08
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Tubing, Noninvasive - DeRoyal2005-06-23
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Bedding Disposable, Medical - DeRoyal2005-04-14
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Dressing, Wound, Occlusive - DeRoyal2004-12-09
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Sheet, Burn - DeRoyal2004-12-09
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Cotton, Roll - DeRoyal2004-10-15
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Dressing, Wound, Hydrophilic - DeRoyal2004-06-23
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Applicator, Absorbent Tipped, Sterile - DeRoyal2004-06-23
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Tape and Bandage, Adhesive - DeRoyal2003-04-04
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Applicator, Absorbent Tipped, Non-Sterile - DeRoyal2001-08-03
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Kit, Surgical Instrument, Disposable - DeRoyal2001-08-03
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Cover, Limb - DeRoyal2001-08-03
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Dissector, Surgical, General & Plastic Surgery - DeRoyal2001-08-03
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Pad, Neonatal Eye - DeRoyal2001-08-03
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Instrument, Surgical, Disposable - DeRoyal2001-02-21
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Tray, Surgical - DeRoyal2001-02-06
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Stax1997-01-13
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Splint, Traction - DeRoyal1997-01-13
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Gauze/Sponge, Nonresorbable for External Use - DeRoyal1994-01-04
Ortho and Surgical Products Enterprises S.A. [DEROYAL INDUSTRIES, INC.]
Joint, Shoulder, External Limb Component - DeRoyal1992-10-28

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