FDA Registration
Active
🇺🇸 United States
OSCOR INC.
Reg #: 1035166
·
FEI: 1035166
·
Expires 2026
Products
14
Proprietary Names
45
Establishment Types
5
Classifications
14
Registration Details
- Registration Name
- OSCOR INC.
- Registration Number
- 1035166
- FEI Number
- 1035166
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4875 Palm Harbor Blvd
- City
- PALM HARBOR
- State
- FL
- ZIP
- 34683
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070926
- PMA Number
- P150009
Owner / Operator
- Firm Name
- OSCOR INC.
- Operator Number
- 1035166
- Address
- 4875 Palm Harbor Blvd, --
- City
- Palm Harbor
- State
- FL
- Postal Code
- 34683
- Country
- US
- Correspondent
- Mohit M Malkani
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2015-03-27 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2007-08-14 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2022-05-23 |
| Pacemaker Lead Adaptor | DTD | Class 2 | Cardiovascular | No | 1992-07-06 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2008-03-05 |
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2013-11-19 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 1992-07-06 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2010-03-06 |
| Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief | QLK | Class 3 | Unknown | No | 2025-07-01 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2023-04-24 |
| Implanted Phrenic Nerve Stimulator For Central Sleep Apnea | PSR | Class 3 | Unknown | No | 2017-10-18 |
| Acute Coronary Syndrome Event Detector | QBI | Class 3 | Unknown | No | 2019-01-10 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2008-09-05 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2017-08-15 |
Proprietary Names
Freedom-4 Stimulator
ATAR
Medtronic (ATAR OEM Brands) 53912D
Medtronic (ATAR OEM Brands) 53912A
Medtronic (ATAR OEM Brands) 53912
EMBSNV20 BSNV-8 Extension Adaptor kit
LEAD ADAPTORS
Adelante
Adelante-S, SafeSheath Ultra with VBT
VS-1
DiREX
Adelante Destino
Vein Picks
TEMPORARY PACING PRODUCTS
Adelante Radial
Angios
Arrive
Adelante Breezeway Delivery Sheath
Vein Pick
Breezeway II
ELECTRODE, PACEMAKER, TEMPORARY
TB
HELIOS
LEAD ADAPTORS AND EXTENSIONS
Adelante-S Lite, Adelante-S2, Adelante-S-RS, Adelante SII, SafeSheath II
Adelante - S Series
VS-32
MC-526
MC-01
Adelante Magnum
Destino Reach
TME 65
TME 64
Port Plug
IS4/DF4 Port Plug
Angel Medical repack of generator, pack and sterilize torque wrench
Destino Twist, Steerable Guiding Sheath
Venos
BSC OEM Model 664760-303, Oscor Model LS21-10
Sitelight(TM) LED Surgical Light, Battery Powered
Adelante Destino Steerable Guiding Sheath
Sigma Plus
Adelante Sigma
Adelante Targa
Adelante Sigma AT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Repack or Relabel Medical Device