Data / Medical devices / Mexico / Grupo American Industries, S.A. de C.V
Grupo American Industries, S.A. de C.V: FDA-registered device maker in Ciudad Juarez Chihuahua, Mexico, 14 510(k) clearances
Grupo American Industries, S.A. de C.V is registered with the FDA (registration 3013466775) in Ciudad Juarez Chihuahua, Mexico. It lists 33 device types. The FDA files 14 510(k) clearances under its listings, the newest dated April 17, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013466775
- Address
- Valle del Cedro No. 1520, Parque Industrial Intermex, Ciudad Juarez Chihuahua, Mexico, 32575
- Owner or operator
- Beaver-Visitec International, Inc. (10033379)
- Roles
- Exporter to the US
- First device listed
- August 10, 2010
- Registered through
- 2026
- Brand names listed
- 45 Degree Toothed Forceps, 50 Cannula, Accu-Temp High Temperature Cautery, Accu-Temp High Temperature Cautery Handle, Accu-Temp Interchangeable Fine Tip, Accu-Temp Interchangeable Loop Tip, Accu-Temp Low Temperature Cautery, Accu-Temp Low Temperature Cautery Handle 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 |
|---|---|---|---|---|---|---|
| April 17, 2017 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| August 2, 2011 | K111067 | JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE | FYA | Substantially Equivalent | Kunshan Jiehong Nonwoven Product Co., Ltd. | accessdata.fda.gov |
| June 4, 2009 | K090938 | FLOW CONTROLLER | LZU | Substantially Equivalent | Odyssey Medical, Inc. | accessdata.fda.gov |
| June 27, 2002 | K013613 | SOFT PLUG ABSORBABLE PLUG-SA | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| March 12, 2001 | K010572 | BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE | KKX | Substantially Equivalent | Becton, Dickinson and Co. | accessdata.fda.gov |
| September 9, 1997 | K972523 | PUNCTUAL OCCLUDER | LZU | Substantially Equivalent | Odyssey Medical, Inc. | accessdata.fda.gov |
| April 23, 1997 | K970631 | PUNCTUAL OCCLUDER | LZU | Substantially Equivalent | Odyssey Medical, Inc. | accessdata.fda.gov |
| February 7, 1995 | K946357 | COLLAGEN INTRACANALICULAR PLUG | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| September 30, 1992 | K923645 | VISITEC ASPIRATING SYRINGE | FMF | Substantially Equivalent | Visitec Co. | accessdata.fda.gov |
| May 2, 1991 | K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 | GEI | Substantially Equivalent | Mentor O & O, Inc. | accessdata.fda.gov |
| May 18, 1990 | K900786 | VISI-SORB ABSORBANT STICK | HOZ | Substantially Equivalent | Visitec Co. | accessdata.fda.gov |
| November 29, 1983 | K833648 | OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S | HAM | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
| December 17, 1980 | K802845 | CONCEPT CANALICULUS INTUBATION SET | HNL | Substantially Equivalent | Concept, Inc. | accessdata.fda.gov |
| July 11, 1977 | K771189 | HOT TEMP CAUTERY | HQP | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, Ophthalmic
- All makers of Cannula, Ophthalmic
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Plug, Punctum
- All makers of Knife, Ear
- All makers of Syringe, Piston
Updated April 17, 2017. 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.