Data / Medical devices / Guatemala / Ortho and Surgical Products Enterprises S.A.
Ortho and Surgical Products Enterprises S.A.: FDA-registered device maker in Villa Canales Guatemala, Guatemala, 4 510(k) clearances
Ortho and Surgical Products Enterprises S.A. is registered with the FDA (registration 3010452421) in Villa Canales Guatemala, Guatemala. It lists 75 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 16, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010452421
- Address
- KM 20.5 Carretera a Villa Canales Zona 3 Finca Morancito, Villa Canales Guatemala, Guatemala, 01065
- Owner or operator
- DEROYAL INDUSTRIES, INC. (1044833)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- October 28, 1992
- Registered through
- 2026
- Brand names listed
- Accessories, Operating-Room, Table (Kit) - DeRoyal, Accessories, Traction - DeRoyal, Aid, Transfer - DeRoyal, Applicator, Absorbent Tipped, Non-Sterile - DeRoyal, Applicator, Absorbent Tipped, Sterile - DeRoyal, Bandage, Cast - DeRoyal, Bandage, Elastic - DeRoyal, Bed, Ac-Powered Adjustable Hospital - DeRoyal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Traction | ILZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Contract manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 | Contract manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer | accessdata.fda.gov |
| Binder, Abdominal | FSD | 1 | Contract manufacturer | accessdata.fda.gov |
| Burn Kit Without Drug | OJJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Peritoneal | GBW | 1 | Contract manufacturer | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Contract manufacturer | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cover, Limb | IPM | 1 | Contract manufacturer | accessdata.fda.gov |
| Crutch | IPR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Contract manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Contract manufacturer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Contract manufacturer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing Change Tray | OXQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Exerciser, Powered | BXB | 1 | Contract manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Contract manufacturer | accessdata.fda.gov |
| Gauze/Sponge, Internal | EFQ | U | Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Contract manufacturer | accessdata.fda.gov |
| Halter, Head, Traction | HSS | 1 | Contract manufacturer | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Contract manufacturer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Joint, Shoulder, External Limb Component | IQQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Contract manufacturer | accessdata.fda.gov |
| Pad, Neonatal Eye | FOK | 1 | Contract manufacturer | accessdata.fda.gov |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Contract manufacturer | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Restraint, Wheelchair, Non-Protective | KID | 1 | Contract manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Contract manufacturer | accessdata.fda.gov |
| Sheet, Burn | FPY | 1 | Contract manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Contract manufacturer | accessdata.fda.gov |
| Splint, Clavicle | IQJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Contract manufacturer | accessdata.fda.gov |
| Splint, Traction | HSP | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Contract manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Natural | GAL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Contract manufacturer | accessdata.fda.gov |
| Tube, Levine | FRQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| July 16, 2007 | K070936 | WELMED HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 10, 1982 | K820442 | ARGYLE INDWELL FEEDING TUBE | KNT | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| November 5, 1979 | K791871 | NEUROLOGICAL SPONGES (PATTIES) | EFQ | Substantially Equivalent | Carwild Corp. | accessdata.fda.gov |
Compare with other makers
Updated July 16, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.