FDA Registration
Active
🇵🇭 Philippines
Transmedic Philippines Inc.
Reg #: 3020899789
·
FEI: 3020899789
·
Expires 2026
Products
31
Proprietary Names
22
Establishment Types
1
Classifications
31
Registration Details
- Registration Name
- Transmedic Philippines Inc.
- Registration Number
- 3020899789
- FEI Number
- 3020899789
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9F Petron Mega Plaza, #358 Sen. Gil, Puyat Avenue, Brgy., Bel-Air
- City
- Makati City Manila
- Country
- PH
Regulatory Submissions
- 510(k) Number
- K080560
Owner / Operator
- Firm Name
- Transmedic Philippines Inc.
- Operator Number
- 10084837
- Address
- 9F Petron Mega Plaza, #358 Sen. Gil, Puyat Avenue, Brgy., Bel-Air
- City
- Makati City
- State
- Manila
- Postal Code
- 1209
- Country
- PH
US Agent
- Business Name
- Arthrex Inc
- Contact Name
- Barry Dietz
- Address
- 1370 Creekside Blvd
- City
- Naples
- State
- FL
- ZIP
- 34108
- Country
- US
- [email protected]
- Phone
- 800 9337001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2023-08-04 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2022-06-02 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2022-04-06 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2022-04-06 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-04-06 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2022-04-06 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2022-04-06 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2023-08-04 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2022-04-06 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2022-04-06 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-07-24 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2025-07-24 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2023-08-04 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-04-06 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2022-04-06 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2022-06-02 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2022-06-02 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2023-12-08 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2022-06-02 |
| Probe | HXB | Class 1 | Orthopedic | No | 2023-12-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-06-02 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-12-08 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2024-02-09 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-06-02 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-08-27 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2023-08-04 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2022-06-10 |
| Camera, Television, Surgical, Without Audio | FWB | Class 1 | General, Plastic Surgery | No | 2025-07-24 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2022-06-02 |
Proprietary Names
Bedding, Disposable, Medical
Table And Attachments, Operating-Room
Rongeur
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
PUNCH, SURGICAL
Instrument, Manual, Surgical, General Use
Apparatus, Traction, Non-Powered
Component, Traction, Non-Invasive
MENISCAL CINCH
Accessories, Arthroscopic
PROBE
Orthopedic Manual Surgical Instrument
MALLET, SURGICAL, GENERAL & PLASTIC SURGERY
MINI TIGHTROPE
PCL TIGHTROPE
BURR, SURGICAL, GENERAL & PLASTIC SURGERY
Bit, Drill
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Protector, Skin Pressure
Camera, Surgical And Accessories
CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
Blade, Saw, General & Plastic Surgery, Surgical
Establishment Types
Export Device to the United States But Perform No Other Operation on Device