FDA Registration Active 🇩🇴 Dominican Republic

Covidien

Reg #: 9612501 · FEI: 3003495548 · Expires 2026
Products
64
Proprietary Names
168
Establishment Types
2
Classifications
64

Registration Details

Registration Name
Covidien
Registration Number
9612501
FEI Number
3003495548
Status
Active
Expiry Year
2026
Initial Importer
No
Address
ZONA FRANCA DE SAN ISIDRO, Carretera San Isidro, Km 17
City
- Santo Domingo
Country
DO

Regulatory Submissions

510(k) Number
K062779

Owner / Operator

Firm Name
Covidien llc
Operator Number
1282497
Address
15 HAMPSHIRE STREET, --
City
Mansfield
State
MA
Postal Code
02048
Country
US

Products

Device Name Product Code
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
Laparoscope, General & Plastic Surgery GCJ
Anti Fog Solution And Accessories, Endoscopy OCT
Splint, Intranasal Septal LYA
Replacement, Ossicular Prosthesis, Total ETA
Esophagoscope (Flexible Or Rigid) EOX
Gouge, Surgical, General & Plastic Surgery GDH
Suture, Absorbable, Natural GAL
Trocar, Gastro-Urology FBQ
Stimulator, Nerve ETN
Suture, Nonabsorbable, Silk GAP
Clip, Implantable FZP
Applier, Surgical, Clip GDO
Neurosurgical Paddie HBA
Tube, Tympanostomy ETD
Shunt, Central Nervous System And Components JXG
Container, Specimen, Sterile FMH
Stylet, Tracheal Tube BSR
Endoscopic Tissue Approximation Device OCW
Device, Monitoring, Intracranial Pressure GWM
Catheter, Ventricular HCA
Staple, Removable (Skin) GDT
Cannula, Ophthalmic HMX
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene LBN
Electrode, Needle GXZ
Balloon, Epistaxis EMX
Port & Catheter, Implanted, Subcutaneous, Intraventricular LKG
Porous Polyethylene Ossicular Replacement LBM
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Button, Nasal Septal LFB
Catheter, Continuous Flush KRA
Catheter, Percutaneous, Intraspinal, Short Term MAJ
Laryngoscope, Endoscope GCI
Electromyograph, Diagnostic IKN
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Stimulator, Electrical, Evoked Response GWF
Prosthesis, Partial Ossicular Replacement ETB
Suture, Nonabsorbable, Synthetic, Polyamide GAR
Arthroscope HRX
Microrule, Ent KAH
Motor, Drill, Electric HBC
Staple, Implantable GDW
Suture Kit OVN
Accessories, Cleaning Brushes, For Endoscope MNL
Tape, Surgical, Internal MCA
Modular Electromechanical Surgical System SCV
Plate, Cranioplasty, Preformed, Non-Alterable GXN
Cover, Burr Hole GXR
Tube, Ear Suction JZF
Tube, Tracheal (W/Wo Connector) BTR
Device, Occlusion, Umbilical FOD
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
Nasopharyngoscope (Flexible Or Rigid) EOB
Splint, Nasal EPP
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
Electrode, Needle, Diagnostic Electromyograph IKT
Material, External Aesthetic Restoration, No Adhesive NOK
Laparoscope, Gynecologic (And Accessories) HET
Bur, Ear, Nose And Throat EQJ
Needle, Hypodermic, Single Lumen FMI

Proprietary Names

Micro-Craft System XOMED Silicone Block/Strip Clearify ENDO CLOSE Nasal Splint Hydroxylapatite Ossicular Replacement Prosthesis Trans-Nasal Esophogoscope EndoSheath System SURGIPORT Shea Middle Ear Microdrill SurgiGut SURGIPORT SPIRAL SLEEVE Thoracoport VARI-STIM III Nerve Locator Sofsilk Versaport Bladeless Optical Trocar VersaOne™ Bladeless Trocar Endo Clip III Neuray Surgical Patties and Strips Hoffman N/V coated longer term VT (w/Liner) Strata NSC Burr Hole Valve, Model 42335, Shunt Assembly, Model 46635 Total Ossicular Replacement Posthesis Juhn Tym-Tap Tube-Stat Lighted Intubation Stylets, Naso-Tracheal; Oro-Trachel Stylet ENDO SLIDE ENDO STITCH Intracranial Pressuring Monitoring Syst. PS Medical Button Valve Blunt Tip Trocars Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102 Surgiwip MULTAPPLIER Endo Clip MultApplier CLIP IMPLANTABLE CSF-FLOW CONTROL VALVE, ULTRA SMALL STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 SFS Stapler McKesson Skin Staplers 35 REGULAR Appose Skin Staplers Signet McKesson Skin Staplers 35 WIDE ConcordeMultifire Premium skin stapler PRISMA DISPOSABLE U-SHAPED CANNULA Polysorb™ Coated Braided Absorbable Suture TiCron PS Medical Delta Burr Hole Valve Surgiclip" Versastep Nicolet Disposable Prass Probe Total Ossicular Replacement Concentric Needle Electrode VersaOne™ 5mm bladed trocar Epistaxis Balloon CSF-Ventriculostomy Reservoir Versaport V2 Bladeless Optical Trocar Step Austin Modified Ttotal Ossicular replacement SurgiTie Gut Fish Modified Total Ossicular Prosthesis Polypropylene Suture Austin Modified Total Ossicular Replacement VersaOne optical trocar with fixation balloon cannula VersaOne universal fixation balloon cannula Versaport RPF ENDO MINI-RETRACT Total Occicular replacement Rebar IPI Algo-Line Catheter Surgical Nerve Stimulator/Locator ENDO CATCH PS MEDICAL DELTA CSF-FLOW CONTROL VALVE P-S Med. Lumbo Peritoneal & Ventriculo Visiport Versaport Bladeless NIM PRS IPC Powerease System Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701 ahd 41704-41715 P-S Medical CSF-Lumboperitoneal Shunt CSF-Ventricular Catheter, Standard Des McGee Modified SS Piston Maxon Activent Ventilation Tube Dermalon & Surgilon P-S Medical CSF-Flow Control Valve Bur Nerve Integrity Monitor 3 Medtronic PS Medical Niveau Drainage System, Pole Clamp VersaOne™ Bladeless and Optical 15mm One Step DG Surgilene Suture P-S Medical Ventricular Access Port CSF-Flow Control Valve, Ultra Small Versaport v2 MicroRuler, ENT P-S MEDICAL CSF-FLOW CONTROL VALVE Bluntport Sofsilk™ Coated Braided Silk Suture Doubletime Trocar Electric Drill System, IPC Endo GIA Pancreas Indication Caprosyn Bucket Prosthesis P-S CSF-Ventricular Catheter, Flanged Nerve Intergrity Monitor - 2XL (NIM 2XL) PS Medical Bioglide CSF-Flow Control Shunt Kit Ventilation (Tympanostomy) Tubes CSF-Cardiac/Peritoneal Catheter Suture Convenience Kit P-S Medical CSF-Siphon Control Device Becker External Drainage/Monitor SYS Lumbar Cath. Monosof Clearify Trocar Wipe Strata BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM Echelon P-S Medical CSF Access Dev 15MM/25MM TriVantage Next Generation EMG Endo Tracheal Tube VERSAPORT ArthroPort VERSASEAL VersaOne™ Bladed and Bladeless Trocars Medtronics PS Medical External Drainage and Monitoring (EDM) Ventricular Catheter, 20CM and 35 CM Model 96115 and 96118 SurgiPro II StrataMR™ II Valves and Shunts Versaport V2 Polyester Tape Hugo™ Robotically Assisted Surgery (RAS) System Endo Clip lll Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900 Surgipro Tube, Ear Suction MINI STEP Hunsake Jet Ventilation Tube Umbilical Tape CSF-CARDIAC/PERITONEAL CATHETER Ossicular Replacement Biosyn Stainless Steel Sutures SMALL LUMEN PERITONEAL CATHETER Bralon & Surgidac PS Medical Strata II Valve NIM- Spine ALAR Nasal Valve Stent Novafil & Vascufil IO+ Port Spacemaker Balloon Dissector EndoSaph Vein Harvest System Stimulation/Dissection Instruments Endosheath System PDB Sterile Balloon Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and without Bioglide Ceravical Ceramic Ossicular Replacement Prostesis Gut Suture BRIDGEMASTER SPLINT Pledgets AccuGuide Injection Monitor, Needle Electrode Xomed Platinum Wire Teflon Piston Polysorb MEDTRONIC PS MEDICAL STRATA TYPE VALVE Versaport External aesthetic restoration Prosthesis Versastep V2 Silicone Sheets - Ear, Nose and Throat Synthetic polymer material Ear, Nose and Throat Burs Soft Hydroxylapatite Ossicular Malleable Disposable Hypodermic Needle Electrode MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM Fisch Modified Tef Wire Piston TM Patcher Tympanic Memebrane Patch Titanium Middle Ear Prosthesis

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device