FDA Registration
Active
🇺🇸 United States
TERUMO MEDICAL CORP.
Reg #: 1118880
·
FEI: 1118880
·
Expires 2026
Products
8
Proprietary Names
29
Establishment Types
5
Classifications
8
Registration Details
- Registration Name
- TERUMO MEDICAL CORP.
- Registration Number
- 1118880
- FEI Number
- 1118880
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 950 ELKTON BLVD.
- City
- ELKTON
- State
- MD
- ZIP
- 21921
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152173
- PMA Number
- P930038
Owner / Operator
- Firm Name
- TERUMO MEDICAL CORP.
- Operator Number
- 9003933
- Address
- 265 Davidson Avenue, Ste. 320
- City
- Somerset
- State
- NJ
- Postal Code
- 08873
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | DRY | Class 2 | Cardiovascular | No | 2009-12-01 |
| Stabilizer, Heart | MWS | Class 1 | Cardiovascular | No | 2026-02-05 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2015-12-14 |
| Device, Hemostasis, Vascular | MGB | Class 3 | Unknown | No | 2017-01-25 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-12-03 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2022-01-11 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2023-07-31 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2006-01-18 |
Proprietary Names
CDI Shunt Sensor
Holder, Suture Holder
Assistant Attachment with StableSoft Technology
Assistant Flex Attachment with StableSoft Technology
Stabilizer II with StableSoft Technology
Glidesheath
Glidesheath Slender
MedAmicus Coaxial Introducer
Angio-Seal VIP Vascular Closure Device
Angio-Seal
Glidewire GT,
Glidewire Gold
Radifocus Glidewire,
Mandrel Guidewire Assembly
Glidesheath Slender Tibial Pedal Kit
Radifocus Introducer II with R/O Marker
Pinnacle R/O II
TR Band Radial Compression Device
R2P NaviCross
TR BAND® Radial Compression Device; TR Band
Manan GWI Guide Wire Introducer
Pinnacle R/O II HiFlo
Nagare Bi-Directional Steerable Sheath
Radifocus Introducer II
Pinnacle Introducer Sheath
Pinnacle Precision Access System
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
R2P Destination Slender Guiding Sheath
R2P Destination Slender Guiding Sheath
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Device in the United States for Export Only