Data / Medical devices / Dominican Republic / Farmaco Quimica Nacional, S.A.
Farmaco Quimica Nacional, S.A.: FDA-registered device maker in La Esperilla Santo Domingo, Dominican Republic, 42 510(k) clearances
Farmaco Quimica Nacional, S.A. is registered with the FDA (registration 3003755939) in La Esperilla Santo Domingo, Dominican Republic. It lists 34 device types. The FDA files 42 510(k) clearances under its listings, the newest dated October 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003755939
- Address
- Calle Jose Aybar Castellanos, No. 155, La Esperilla Santo Domingo, Dominican Republic, 10107
- Owner or operator
- Farmaco Quimica Nacional, S.A. (10083312)
- Roles
- Exporter to the US
- First device listed
- November 10, 2021
- Registered through
- 2026
- Brand names listed
- Accessories, arthroscopic, Apparatus, traction, non-powered, BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL, BUR, SURGICAL, GENERAL & PLASTIC SURGERY, Bit, Drill, CAMERA, SURGICAL AND ACCESSORIES, INSTRUMENT, MANUAL, SURGICAL, GENERAL USE, INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE 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 |
|---|---|---|---|---|---|---|
| October 6, 2023 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 24, 2023 | K223759 | Arthrex SynergyID Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| April 19, 2021 | K203495 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202535 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 4, 2020 | K202581 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 19, 2019 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| May 26, 2017 | K171296 | SutureTape | GAT | 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 |
| August 20, 2015 | K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 2, 2015 | K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 18, 2014 | K140855 | ARTHREX SUTURETAK SUTURE ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 31, 2013 | K132043 | ARTHREX SPEEDCINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 2, 2013 | K130350 | PROCELLERA | FRO | Substantially Equivalent | Vomaris Innovations, 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 |
| March 8, 2012 | K120044 | ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED | KWS | 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 |
| 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 |
| June 26, 2009 | K083435 | ARTHREX UNIVERS II SHOULDER PEGGED GLENOID | KWS | 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 20, 2007 | K071032 | ARTHREX UNIVERS II SHOULDER PROSTHESIS | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 3, 2007 | K071176 | MODIFICATION TO: ARTHREX INTERFERENCE SCREW | MAI | 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 |
| April 27, 2006 | K060089 | TULIP DISPOSABLE CANNULAS | QPB | Substantially Equivalent | Cell Bio-Systems, Inc. | accessdata.fda.gov |
| April 3, 2006 | K053543 | ARTHREX ARTHOERESIS IMPLANT | 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 |
| 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 |
| February 5, 2004 | K030837 | 40 L HIGH FLOW INSUFFLATOR F108 | HIF | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| March 20, 2003 | K024291 | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 17, 2002 | K023986 | ARTHREX OPES ELECTRODES AND ACCESSORIES | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 6, 2001 | K010124 | ARTHREX UNIVERS 30 SHOULDER PROSTHESIS | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 22, 1996 | K953913 | OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES | HRX | Substantially Equivalent | Optus, Inc. | accessdata.fda.gov |
| February 1, 1995 | K943492 | ARTHREX STAPLES | JDR | Substantially Equivalent for Some Indications | 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 Pin, Fixation, Smooth
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Screw, Fixation, Bone
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Updated October 6, 2023. 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.