FDA Registration
Active
🇮🇪 Ireland
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
Reg #: 9616696
·
FEI: 3003164255
·
Expires 2026
Products
18
Proprietary Names
93
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- STRYKER IRELAND LTD., INSTRUMENTS DIVISION
- Registration Number
- 9616696
- FEI Number
- 3003164255
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CARRIGTWOHILL BUSINESS &, TECHNOLOGY PARK
- City
- CARRIGTWOHILL, CO.CORK Munster
- Country
- IE
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 INSTRUMENTS
- Contact Name
- Kim Wiersema
- Address
- 1941 Stryker Way, -
- City
- Portage
- State
- MI
- ZIP
- 49002
- Country
- US
- [email protected]
- Phone
- 269 2545351
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2015-05-03 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2015-05-03 |
| Bur, Dental | EJL | Class 1 | Dental | No | 1992-12-22 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 1995-07-11 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2007-12-03 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 1995-07-11 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2015-09-24 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2006-12-12 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 1996-02-06 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2004-11-15 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2022-02-17 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2009-05-20 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 1992-12-26 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2009-04-30 |
| Instrument, Cast Removal, Ac-Powered | LGH | Class 1 | Orthopedic | No | 2006-12-12 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2011-11-28 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2004-11-15 |
| Blade, Saw, Surgical, Cardiovascular | DWH | Class 1 | General, Plastic Surgery | No | 2006-12-12 |
Proprietary Names
Stryker(R) Consolidated Operating Room Equipment (CORE) System
4cm Angled Irrigation Clip
4cm Straight Irrigation Clip
RemB Micro Drill
5MM FLEXIBLE REAMER
6MM FLEXIBLE REAMER
11MM FLEXIBLE REAMER
7.5MM FLEXIBLE REAMER
4.5MM FLEXIBLE REAMER
7MM FLEXIBLE REAMER
12MM FLEXIBLE REAMER
11.5MM FLEXIBLE REAMER
8MM FLEXIBLE REAMER
6.5MM FLEXIBLE REAMER
9.5MM FLEXIBLE REAMER
FLEXIBLE GUIDE PIN
VERSITOMIC STERILE FLEXIBLE PIN
10MM FLEXIBLE REAMER
5.5MM FLEXIBLE REAMER
8.5MM FLEXIBLE REAMER
9MM FLEXIBLE REAMER
10.5MM FLEXIBLE REAMER
AEQUALIS REVERSED
BIT
General Surgical Bits
Stryker Aria Pneumatic System
RIO PKA System
NexFix
IMN Instruments drill
Made-To-Order
Tornier Simpliciti Shoulder System
MaxTorque
Compression Staple System
Latitude EV
Aequalis Perform+
CalcLock
MaxLock
Tornier Perform Humeral System
Tornier Perform Reversed
Pangea Torque Limiting Adapter
Aequalis Flex Revive
Tornier Extraction
Tornier Humeral Nail
Pangea Platform
Hoffmann LRF
4 mm ENT MicroDebrider JAGUAR
Mako Partial Knee
0485-840-000 - XL Round Diamond Bur, 4 mm
0485-860-000 - XL Round Diamond Bur, 5.5 mm
Dual Edge Shaver Blade 4mm
Dual Edge Shaver Blade 5.5mm
Tomcat HC Shaver Blade 4mm
Aggressive Max Shaver Blade 3.5mm
Smooth Bite Shaver Blade 3.5mm
Dual Edge Shaver Blade 3.5mm
Bursector 5.5 mm
Bursector 4 mm
12cm iQ Apex 360
12cm iQ Standard
10cm iQ Broad Knife
12cm iQ Serrated Large
12cm iQ Barracuda
12cm iQ Large
18cm iQ Apex Micro Claw
SONOPET IQ CONSOLE
18cm iQ Micro Claw
12cm iQ Micro
12cm iQ 120 Claw
11cm iQ Knife
12cm iQ Micro Claw
12cm iQ Claw
20cm iQ Apex 360
11cm iQ Apex Knife
20cm iQ Standard
add name
Stryker Leibinger Colorado Microdissection Needle
7.5MM Round
IRRIGATION
Mako TKA System
ORTHOVAC
CASTVAC
Kirschner Wire
4mm TomCat Shaver Blades
5mm HellCat Shaver Blades
ATTACHMENTS
PKG., DUAL EDGE SHAVER BLADE - 5.5MM
HMENTS
SURGICAL INSTRUMENT MOTORS AND ACCE
SMOOTH BITE SHAVER BLADE - 3.5MM
SAW BLADE
HLS KNEETEC
PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM
Mako Shoulder Application
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)