FDA Registration
Active
🇨🇦 Canada
Stryker Endoscopy
Reg #: 3015439135
·
FEI: 3015439135
·
Expires 2026
Products
3
Proprietary Names
22
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Stryker Endoscopy
- Registration Number
- 3015439135
- FEI Number
- 3015439135
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 50 Wellington Street East, Suite 400
- City
- Toronto Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K234149
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
US Agent
- Business Name
- Stryker Endoscopy
- Contact Name
- April Malmborg
- Address
- 5900 Optical Ct.
- City
- San Jose
- State
- CA
- ZIP
- 95138
- Country
- US
- [email protected]
- Phone
- 408 4093115
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2024-10-29 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1992-12-15 |
| Endoscopic Magnetic Retriever, Exempt | PTQ | Class 2 | Gastroenterology, Urology | No | 2024-08-15 |
Proprietary Names
MP2015A MOLLI OncoPen
MT2001 MOLLI 2 Tablet
MP2025S MOLLI OncoPen Prime
MP2040S MOLLI OncoPen Elite
MM1000 MOLLI Introducer (8cm, 14G) and MOLLI Marker
MP2001 MOLLI 2 Wand
MS-00009 MOLLI Introducer (12cm, 14G) and MOLLI Marker
MM1000 MOLLI Marker 8cm w/ Introducer
MOLLI 2
MS-00009 MOLLI Marker 12 cm w/ Introducer
MM1000 MOLLI Marker and Introducer (8 cm)
MS-00009 MOLLI Marker and Introducer (12 cm)
MP2001 Molli 2 Wand
MT2001 Molli 2 Tablet
MP2015A Molli OncoPen
IV Pole
THC5 Stand
TPS2 Stand
Infusion Stand
MS -00017 MOLLI Pole Clamp
Hydro Pole Mount
RM0112 re.markable
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility