FDA Registration
Active
🇺🇸 United States
Covidien
Reg #: 3008361498
·
FEI: 3008361498
·
Expires 2026
Products
9
Proprietary Names
59
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- Covidien
- Registration Number
- 3008361498
- FEI Number
- 3008361498
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2800 Airwest Blvd, Suite 160
- City
- Plainfield
- State
- IN
- ZIP
- 46168
- Country
- US
Regulatory Submissions
- 510(k) Number
- K801153
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 |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-04-11 |
| Electrode, Electrosurgical | JOS | Class 2 | General, Plastic Surgery | No | 2007-12-11 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-11-30 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2014-05-16 |
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2023-07-28 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2000-05-02 |
| System, Imaging, Gastrointestinal, Wireless, Capsule | NEZ | Class 2 | Gastroenterology, Urology | No | 2022-06-29 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2008-02-26 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2008-02-26 |
Proprietary Names
Valleylab Blade Electrode
Valleylab¿ Ball Electrode
Valleylab¿ Straight Extension
Valleylab Needle Electrode
Valleylab Tungsten Loop Electrode, Reusable, 9.5 mm, E1005
Valleylab Needle Electrode, 2.8" (7.2 cm), E1552NSB
Valleylab Ball Electrode, Reusable, 5.6 mm, E1002
Valleylab Hex-locking Blade Electrode, 2.4" (6.2 cm), E1551XNSB
Valleylab Ball Electrode, 6.5" (16.51 cm), E1551-6NSB
Valleylab Straight Extension, 34.3 cm, E1504
Valleylab Needle Electrode, 2.8" (7.2 cm), E1552
Valleylab Fine -Needle Electrode, Reusable, 2.6" (6.6 cm), E1003
Valleylab Ball Electrode, Reusable, 3.2 mm, E1000
Valleylab Straight Extension, 13 cm, E1502
Valleylab Ball Electrode, 5 mm, E1550
Valleylab Return Electrode Monitor
Valleylab Multiple Return/S Cord Adapter, E0507-B
Emprint Microwave Ablation System- CAMSYS
Footswitch- RFASW; & Remote Temperature Probe- RTP20
Includes Generator- CAGEN1; Percutaneous Antenna- CA15L1, CA20L1, CA30L1; Pump- CAPUMP1; Reusable Cable- CA190RC1
Current Monitor E3351
Current Monitor E3350
Endoflip 300 System
Pediatric-Infant Adhesive Sensor Wrap
Adult-Neonatal Adhesive Sensor Wrap
Adult-Neonatal Foam Sensor Wrap
Pediatric-Infant Foam Sensor Wrap
Force Argon II System
Valleylab Argon Tank Regulator, GR200A-20
Valleylab Argon Tank Regulator, GR200A
Emprint Ablation System with Thermosphere Technology
Monopolar Cords
ForceTriad Bipolar Resection Activation Kit
ForceTriad Bipolar Resection Activation Kit, FTBRKIT
Bipolar Forceps Cord
ForceTriad Bipolar Resection Cord Stroz, Reusable, 15' (4.6m), FT0021S
ForceTriad Monopolar Cord 15' (4.6 m), FT0510
ForceTriad Bipolar Resection Cord Wolf, Reusable, 15' (4.6m), FT0022W
Valleylab Bipolar Forceps Cord, 12' (3.6 m), E0512
PillCam capsule
ForceTriad Remote Control Activation Kit, FTRCKIT
Adapters
Valleylab REM Patient Return Electrode Adapter, E0600
Valleylab Monopolar Adapter , E0502-1
Valleylab Universal Monopolar Adapter, E0017
Valleylab Active Adapter, E0005-3C
Oximax Pulse Oximetry System
Emprint SX Table Top Field Generator Cart (CAFGCART1)
Emprint SX Laparoscopic Ultrasound Tracking Sensor (CABK8666L)
Emprint SX Ablation Platform (CASYS100)
Emprint SX Laparoscopic Ultrasound Tracking Sensor (CAAL9150L)
Emprint SX Open Ultrasound Tracking Sensor (CAAL9132)
Emprint SX Field Generator Spacers (Bed Pads) (CAFGSP1)
Emprint Standard Navigation Antenna with Thermosphere Technology (CA20L2N)
Emprint SX Table Top Field Generator (CAFG1)
Emprint SX Ultrasound Surgical Navigation (software) Application (CAUS1SN)
Emprint SX Long Navigation Antenna with Thermosphere Technology (CA30L3N)
Emprint SX Short Navigation Antenna with Thermosphere Technology (CA15L2N)
Emprint SX Open Ultrasound Tracking Sensor (CABK8816)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Manufacture Device in the United States for Export Only