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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2018-05-11 |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | Class 2 | Ear, Nose, Throat | No | 2022-07-13 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2014-10-24 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2014-10-24 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2018-05-11 |
| Replacement, Ossicular Prosthesis, Total | ETA | Class 2 | Ear, Nose, Throat | No | 2018-05-10 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2018-05-11 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2007-04-24 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 1997-12-04 |
| Trocar, Gastro-Urology | FBQ | Class 2 | Gastroenterology, Urology | No | 2007-04-24 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2021-04-07 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2007-11-16 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2010-03-05 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2010-03-05 |
| Neurosurgical Paddie | HBA | Class 2 | Neurology | No | 2018-04-27 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2018-05-11 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2018-05-04 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2018-05-11 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2018-04-27 |
| Endoscopic Tissue Approximation Device | OCW | Class 2 | Gastroenterology, Urology | No | 1994-07-11 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2018-05-04 |
| Catheter, Ventricular | HCA | Class 2 | Neurology | No | 2018-05-04 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2007-12-10 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2018-07-12 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2020-12-11 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2007-11-16 |
| Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene | LBN | Class 2 | Ear, Nose, Throat | No | 2018-05-10 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2018-05-10 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2018-05-10 |
| Port & Catheter, Implanted, Subcutaneous, Intraventricular | LKG | Class 2 | Neurology | No | 2018-05-04 |
| Porous Polyethylene Ossicular Replacement | LBM | Class 2 | Ear, Nose, Throat | No | 2018-05-10 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2010-10-20 |
| Button, Nasal Septal | LFB | Class U | Unknown | No | 2018-05-10 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2021-06-02 |
| Catheter, Percutaneous, Intraspinal, Short Term | MAJ | Class 2 | Anesthesiology | No | 2018-05-04 |
| Laryngoscope, Endoscope | GCI | Class 2 | Gastroenterology, Urology | No | 2007-04-20 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2012-12-13 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-05-11 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2018-05-11 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2018-05-11 |
| Prosthesis, Partial Ossicular Replacement | ETB | Class 2 | Ear, Nose, Throat | No | 2018-05-11 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2007-11-16 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2007-12-14 |
| Microrule, Ent | KAH | Class 1 | Ear, Nose, Throat | No | 2018-05-11 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2018-05-11 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2012-06-04 |
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2016-02-19 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2019-09-18 |
| Tape, Surgical, Internal | MCA | Class 2 | General, Plastic Surgery | No | 2008-01-03 |
| Modular Electromechanical Surgical System | SCV | Class 2 | General, Plastic Surgery | No | 2025-12-05 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2018-05-04 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2018-05-04 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2018-05-11 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2018-05-11 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2005-09-12 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2007-11-16 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2018-05-11 |
| Splint, Nasal | EPP | Class 1 | Ear, Nose, Throat | No | 2019-04-04 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2003-08-11 |
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2018-05-10 |
| Material, External Aesthetic Restoration, No Adhesive | NOK | Class 1 | General, Plastic Surgery | No | 2018-05-11 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2007-12-10 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2018-04-27 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2018-04-27 |
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