Data / Medical devices / Philippines / Transmedic Philippines Inc.
Transmedic Philippines Inc.: FDA-registered device maker in Makati City Manila, Philippines, 35 510(k) clearances
Transmedic Philippines Inc. is registered with the FDA (registration 3020899789) in Makati City Manila, Philippines. It lists 31 device types. The FDA files 35 510(k) clearances under its listings, the newest dated July 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020899789
- Address
- 9F Petron Mega Plaza, #358 Sen. Gil, Puyat Avenue, Brgy., Bel-Air, Makati City Manila, Philippines, 1209
- Owner or operator
- Transmedic Philippines Inc. (10084837)
- Roles
- Exporter to the US
- First device listed
- April 6, 2022
- Registered through
- 2026
- Brand names listed
- Accessories, Arthroscopic, Apparatus, Traction, Non-Powered, BURR, SURGICAL, GENERAL & PLASTIC SURGERY, Bedding, Disposable, Medical, Bit, Drill, Blade, Saw, General & Plastic Surgery, Surgical, CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO, Camera, Surgical And Accessories and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2024 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 4, 2020 | K201134 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 17, 2019 | K183395 | Arthrex 2.5 mm Tenodesis Screw | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 21, 2018 | K181769 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 22, 2018 | K180594 | Knotless SutureTak Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 22, 2018 | K180662 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 9, 2016 | K161581 | Arthrex Synergy RF System | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 12, 2016 | K153218 | Arthrex Synergy UHD4 System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 18, 2014 | K140855 | ARTHREX SUTURETAK SUTURE ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 10, 2014 | K140328 | CMC MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 30, 2014 | K133275 | MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 31, 2013 | K132043 | ARTHREX SPEEDCINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 3, 2013 | K130458 | KNOTLESS FIBERTAK SUTURE ANCHOR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 25, 2012 | K122374 | ARTHREX SUTURE (UHMWPE) | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 19, 2011 | K112990 | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 28, 2011 | K110123 | PCL TIGHTROPE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 7, 2011 | K101823 | ARTHREX SWIVELOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 22, 2010 | K101679 | ARTHREX PUSHLOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 6, 2009 | K090107 | MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 3, 2009 | K083707 | ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 23, 2009 | K082810 | ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| February 11, 2008 | K073149 | MENISCAL CINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 15, 2007 | K071756 | ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE | GCJ | Substantially Equivalent | Pointe Conception Medical, Inc. | accessdata.fda.gov |
| August 3, 2007 | K071176 | MODIFICATION TO: ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 13, 2006 | K063479 | ARTHREX PUSHLOCK | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 29, 2006 | K062466 | ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 19, 2006 | K061863 | ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 13, 2005 | K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 27, 2005 | K051726 | ARTHREX TENODESIS FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 12, 2005 | K050749 | ARTHREX TAK FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 16, 2005 | K043248 | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 20, 2003 | K024291 | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 25, 1994 | K932699 | ARTHREX AR-8200 SHAVER SYSTEM | HWE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 23, 1990 | K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | FST | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Table And Attachments, Operating-Room
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Laparoscope, General & Plastic Surgery
Updated July 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.