Data / Medical devices / Argentina / Crosmed S.A.
Crosmed S.A.: FDA-registered device maker in Buenos Aires, Argentina, 34 510(k) clearances
Crosmed S.A. is registered with the FDA (registration 3012883081) in Buenos Aires, Argentina. It lists 39 device types. The FDA files 34 510(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
- 3012883081
- Address
- Aguirre 545, Buenos Aires, Argentina, 1414
- Owner or operator
- Crosmed S.A. (10085790)
- Roles
- Exporter to the US
- First device listed
- August 9, 2022
- Registered through
- 2026
- Brand names listed
- 40 L HIGH FLOW INSUFFLATOR F108, ARTHREX BIO-PIN, ARTHREX INTERFERENCE SCREW, ARTHREX SWIVELOCK ANCHORS, Accessories, Arthroscopic, Apparatus, Traction, Non-Powered, Arthrex Thrombinator System, Bedding, Disposable, Medical 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 |
| September 9, 2022 | K221354 | Arthrex SutureTape | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202535 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 4, 2020 | K201134 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 12, 2020 | K200341 | Arthrex FiberTak Suture Anchor | 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 |
| 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 |
| September 28, 2017 | K172612 | FiberTak DX | MBI | Substantially Equivalent | Arthex, Inc. | 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 |
| July 7, 2015 | K151543 | Graft Delivery Device with Integrated Stylet | FMF | Substantially Equivalent | Micromedics, Inc. (D/B/A Nordson Medical) | accessdata.fda.gov |
| June 19, 2015 | K151230 | Arthrex FiberTak Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 9, 2015 | K143702 | Arthrex Blunt Tip Screws with Fiber Tape | HTY | 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 15, 2011 | K112040 | ARTHREX BIOCOMPOSITE TRANSFIX | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 7, 2011 | K101823 | ARTHREX SWIVELOCK ANCHORS | MAI | 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 |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, 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 |
| November 29, 2006 | K062466 | ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 19, 2006 | K060478 | ARTHREX BIO-COMPRESSION SCREW | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 27, 2005 | K050259 | ARTHREX BIO-PIN | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 4, 2004 | K041189 | ARTHREX TRIMIT FAMILY | HWC | 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 |
| February 1, 1995 | K943492 | ARTHREX STAPLES | JDR | Substantially Equivalent for Some Indications | Arthrex, Inc. | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, 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 |
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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.