FDA Registration
Active
🇺🇸 United States
Varian Medical Systems, Inc
Reg #: 3008262715
·
FEI: 3008262715
·
Expires 2026
Products
9
Proprietary Names
57
Establishment Types
4
Classifications
9
Registration Details
- Registration Name
- Varian Medical Systems, Inc
- Registration Number
- 3008262715
- FEI Number
- 3008262715
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9825 Spectrum Drive, Building 2
- City
- Austin
- State
- TX
- ZIP
- 78717
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230015
Owner / Operator
- Firm Name
- Varian Medical Systems, Inc
- Operator Number
- 2914292
- Address
- 3100 Hansen Way, --
- City
- Palo Alto
- State
- CA
- Postal Code
- 94304
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2024-09-04 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2020-01-06 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2024-09-23 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-01-07 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2024-10-24 |
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | Class 2 | Cardiovascular | No | 2022-11-02 |
| Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | NOY | Class 2 | Gastroenterology, Urology | No | 2022-11-02 |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | Class 2 | General, Plastic Surgery | No | 2020-01-06 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-01-07 |
Proprietary Names
OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver
MicroThermX Microwave Ablation System - Tabletop Stand (MTX-180-T2)
MicroThermX Microwave Ablation System - Mobile Cart (MTX-180)
Cryocare CS Surgical System
TMC Snap-Off Screw System
Urethral Warming Catheter Kit
Cryocare CS Basic System (CRYO-CS-3 BASIC)
Tempprobe Short (CRYO-55F)
Cryoprobe PERC 2.4MM Slimline Long (PCS-24L)
Endocare 1.7 mm RenalCryo Cryoprobe (RS-17)
Cryoprobe Renal 2.4MM Slimline (RS-24)
Endocare 1.7 mm PerCryo Round Ice Cryoprobe (PCS-17R)
Endocare Prostate Procedure Probe Pack 6 x CVA2400 6 x CRYO-55-F 1 x CRYO-77 (CRYO-207V)
Endocare 1.7 mm RenalCryo Long Shaft Cryoprobe (RS-17L)
Endocare TempProbe Device (CRYO-54F)
Endocare 1.7mm PerCryo Short Cryoprobe (PCS-17RS)
Endocare Cryocare CS System Version 5 (CRYO-CS-3 Version 5)
Endocare Right-Angle 2.4mm V-Probe Cryoprobe (CVA2400RA)
Cryoprobe Renal 1.7MM Slimline Long (RS-17L)
Endocare 1.7mm PerCryo Cryoprobe (PCS-17)
Cryoprobe PERC 2.4MM Slimline (PCS-24)
Endocare 1.7mm PerCryo Cryoprobe Oblong Ice (PCS-17)
Endocare Prostate Procedure Probe Pack 6 (CRYO-207V)
Endocare 3.8mm Long Shaft RenalCryo Cryoprobe (R3.8L)
Endocare 2.4 mm RenalCryo Cryoprobe (RS-24)
Endocare 2.4mm Long Shaft RenalCryo (RS-24L)
Endocare Prostate Procedure Probe Pack 4 (CRYO-204V)
Endocare 1.7mm Round Ice PerCryo Cryoprobe (PCS-17R)
Endocare 2.4 mm PerCryo Long Shaft Cryoprobe (PCS-24L)
Endocare 2.4mm RenalCryo Long Shaft (RS-24L)
Endocare 3.8mm RenalCryo Cryoprobe (R3.8)
Endocare 1.7mm Short PerCryo (PCS-17RS)
Endocare Cryocare CS System Basic (CRYO-CS-3 BASIC)
Round ice short length (PCS-17RS)
Endocare Prostate Procedure Probe Pack 4 x CVA2400 6 x CRYO-55-F 1 x CRYO-77 (CRYO-204V)
Cryoprobe Renal 1.7MM Slimline (RS-17)
Endocare 2.4 mm PerCryo Cryoprobe (PCS-24)
Cryoprobe Renal 2.4MM Slimline Long (RS-24L)
Endocare TempProbe Device (CRYO-55F)
Endocare 2.4mm V-Probe Cryoprobe (CVA2400)
Endocare 2.4mm PerCryo Cryoprobe Oblong Ice (PCS-24)
ONCOZENE Microspheres
TANDEM Microspheres
ONCOZENE® Microspheres
Temperature Sensor Probe (ABL-18TP20)
Embozene Color-Advanced Microspheres
TMC Compression Screw System
Endocare 8mm Cryoprobe (CRYO-48F)
Cryocare SLTM Surgical System
ISOLIS Cryoprobe
TMC Plating System
CRYOCARE TOUCH System and Accessories
IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315)
IntelliBlate Microwave Ablation System Mobile Cart (IB-CART)
IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
IntelliBlate Microwave Ablation System Console (IB-CON)
IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility