FDA Registration
Active
🇲🇽 Mexico
Grupo American Industries, S.A. de C.V
Reg #: 3013466775
·
FEI: 3013466775
·
Expires 2026
Products
33
Proprietary Names
353
Establishment Types
1
Classifications
33
Registration Details
- Registration Name
- Grupo American Industries, S.A. de C.V
- Registration Number
- 3013466775
- FEI Number
- 3013466775
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Valle del Cedro No. 1520, Parque Industrial Intermex
- City
- Ciudad Juarez Chihuahua
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K900786
Owner / Operator
- Firm Name
- Beaver-Visitec International, Inc.
- Operator Number
- 10033379
- Address
- 500 Totten Pond Rd, 10 CityPoint
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
US Agent
- Business Name
- Beaver-Visitec International, Inc.
- Contact Name
- Silvana Brown
- Address
- 303 Wyman St Ste 350
- City
- Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
- [email protected]
- Phone
- 952 7377242
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2016-11-30 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2010-08-11 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2010-08-11 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2010-08-11 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2018-11-29 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2010-08-11 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2010-08-17 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2010-08-11 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2010-08-10 |
| Plug, Punctum | LZU | Class U | Unknown | No | 2013-04-11 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2010-08-11 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2010-08-11 |
| Surgical Eye Tray | PZG | Class 1 | Ophthalmic | No | 2021-05-18 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2011-05-20 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2010-08-11 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2010-08-11 |
| Unit, Cautery, Thermal, Battery-Powered | HQP | Class 2 | Ophthalmic | No | 2014-06-17 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2020-03-10 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2010-08-11 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2021-11-24 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2010-08-12 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2020-03-24 |
| Apparatus, Electrosurgical | HAM | Class 2 | General, Plastic Surgery | No | 2025-01-16 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2010-08-10 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2010-08-11 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2014-12-21 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2021-11-24 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2014-04-04 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2010-08-10 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2021-11-24 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2013-07-23 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2010-08-11 |
Proprietary Names
Beaver Visitec International
Beaver, BVI Beaver Visitec International
Beaver® Myringotomy Blade Upcutting Tip, 45 Degree
Beaver® Spear Tip Myringotomy Knife 45 Degree
Beaver® Myringotomy Blade Downcutting Tip 45 Degree
Beaver® Tympanoplasty Blade, 2.5mm W, 60 Degree Bevel Down
Beaver® Tympanoplasty Blade, 2.5mm W Straight
Beaver® Myringotomy Knife, Lance Tip 45 Degree
Beaver® Myringotomy Blade, Offset 45 Degree
IOL Removal Forceps
45 Degree Toothed Forceps
Sclerectomy Forceps
Thornton Fixation Ring
Fine Stem Toothed Forceps
Max Fine Micro-Corneal Forceps
Fine Toothed Forceps
Iris Pointed Forceps
Iris Fine Toothed Forceps
Fixation Ring
Jewellers Forceps
Contact Lens Forceps
Moorfields Forceps
Corneal Ring Forceps - Keraring
Bishops Forceps
Lens Folding Forceps
Straight Rampley
Scleral Plug Forceps
Lenticule Extraction Forceps
Kocaba DMEK Forceps
Single Use Instrument, Bonn Forceps
MICS Capsulorhexis - Straight/Sharp
Crocodile Forceps
Halstead Mosquito
Jewellers Forceps Angled
Micro Cross-Action Bulldog Clamp
Angled Tying Forceps (McPherson)
Epilation Forceps
Jewellers Forceps, Fine Angled
Curved Tying Forceps
Capsulorhexis Forceps
Toothed Forceps
Birks Tying Forceps
IOL Implantation Forceps
Straight Tying Forceps, Short
Straight Tying Forceps
Catford Forceps
Jewellers Forceps, Fine Straight
Colibri Toothed Forceps
St Martins Forceps
Backhaus Towel Clip
Meibomian Gland Forceps
Kelly Forceps
Punctum Plug Forceps
Adson Forceps Toothed
LASIK Flap-Lifting Forceps
Colibri Notched Forceps
Toothed Forceps (Bonn)
Spencer Wells Artery Forceps
Waqar Suture Removal Forceps
Waughs Dissecting Forceps
Fine Notched Forceps Short (Hoskins)
MICS Capsulorhexis
MICS Capsulorhexis - Straight/Blunt
Colibri Toothed Forceps, Short
Adson Forceps Non-Toothed
Lens Loading Forceps
Jayles Forceps
Iris Pointed Forceps, 105mm
Notched Forceps (Hoskins)
Clip - Long Handled Forceps (Pair)
Barron Scalpel Handle Flat
Beaver Blade Wrench
Dynagrip Handle and Wrench 4mm
Artho-Lok Handle and Wrench 4mm
Beaver Handle (Round Knurled Stainless)
Beaver BeaverTail Flat Handle
Lens Handle
Scalpel Blade Handle With Gradations
Beaver Handle
Beaver Replacement Chuck Collet
Visitec® Absorbent Stick
Guibor Eye Bubble Bandage
Eye Patch
Universal Eye Shield
Left/Right Eye Shield
BVI Maxi-Lite Diagnostic Penlight
BVI Nurse-Mate Six Pack Diagnostic Penlight
BVI Blu-Spot® Diagnostic Penlight
BVI Doctor's Six Pack Diagnostic Penlight
CustomEyes®
Infant Speculum
Wire Eye Speculum
Clarke Speculum
Kratz-Barraquer
Cook Neonatal Speculum
Barrett Speculum
Mechanical Speculum
Paediatric Speculum
Pierce Adjustable Speculum
Corcelle Speculum Solid Blade
Sauer Neonatal Speculum
Kratz-Barraquer Speculum, Curved
Neonatal Speculum
Paediatric Mechanical Speculum
Single use instrument tray Dr. Sunalp
Barraquer Speculum
Alphonso Paediatric Speculum
IOL Manipulator, Jaffe - Maltzman, Blunt tip 45 degree
Kratz-Barraquer Speculum
Kratz-Barraquer Speculum, Temporal
Barraquer Speculum, Solid Blade (PC)
Barraquer Speculum, Flat Blade
Mechanical Speculum, Open Blade (PC)
Parasol® Pre-Loaded Punctal Occluder Medium 0.6mm 0.85mm
Parasol® Quickload Punctal Occluder Large 0.9mm+
Parasol® Pre-Loaded Punctal Occluder Small 0.35mm 0.65mm
Parasol® Punctal Occluder Bulk NS Large 0.9mm+
Parasol® Pre-Loaded Punctal Occluder Large 0.9mm+
Parasol® Quickload Punctal Occluder Combo Pack Small Medium
Parasol® Quickload Punctal Occluder Small 0.35mm 0.65mm
Parasol® Punctal Occluder Bulk NS Small 0.35-0.65mm
Parasol® Quickload Punctal Occluder Medium 0.6mm 0.85mm
Parasol® Pre-Loaded Punctal Occluder X-Small 0.25mm 0.35mm
Parasol® Punctal Occluder Bulk NS Medium 0.6-0.85mm
Parasol® Punctal Occluder Bulk NS Combo Small/Medium
Visitec® Irrigation Handle
Visitec® Single Fluid Administration Set
Visitec® Double Male Luer
Visitec® High Flow Filter
Beaver Ring Cutter Hub
Beaver Ring Cutter
Beaver Ring Cutter Saw Blade
Beaver Ring Cutter Washer
Malosa Core LASIK Pack 2
Malosa IVT Pack
Malosa Phaco Kit
Readypak
Malosa Strabismus Pack
Malosa Corneal Pack
Malosa Core SMILE Pack
Malosa Core LASIK Pack
Malosa Chalazion Pack
Malosa Paediatric Retinal Exam Pack
Malosa IVT Dual Marker Pack
Malosa Core Surface Treatment Pack
Malosa Sub-Tenons Pack
Malosa Core Phaco Pack
Malosa Oculoplastic Suture Pack
Malosa Core SMILE Pack 1
Merocel Diamond Cleaning Block
I-Ring® Pupil Expander
Beaver® Swivel Fixation Ring
Sharp Cystotome, straight
Sharp Point Cystotome
Blunt Tip Irrigating Cystotome
Irrigating Cystotome
GLAUCOMA REVISION PICK
Plus Punctal Occluder
Plus Pre-loaded Punctal Occluder
Accu-Temp High Temperature Cautery Handle
Accu-Temp Interchangeable Fine Tip
Accu-Temp Low Temperature Cautery Handle
Accu-Temp Interchangeable Loop Tip
BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE
BVI Visidrape® Embossed Plastic Incise Drape with Fluid Collection Bag 101.5 x 127cm (40 x 50 in)
BVI Visidrape® Non-Woven Incise Drape with Channel Bag 140 x 127cm (55 x 50 in)
BVI Visidrape® Non-Woven Incise Drape with Fluid Collection Bag 101.5 x 127cm (40 x 50 in)
BVI Visitec® Eye Fluid Wick, .40 x 15cm (5/32 x 5 7/8 in)
BVI Visidrape® Refractive Drape Kit Aperture Drape 60 x 40cm Plain Drape 60 x 56.25cm
BVI Visidrape® Full Body Incise Drape with Plastic Head and Channel Bag 165 x 254cm (65 x 100 in)
BVI Visidrape® Mini Plastic Aperture Drape 41 x 41cm (16 x 16 in)
BVI Visidrape® Non-Woven Full Body Aperture Drape 165 x 254cm (65 x 100 in)
BVI Visitec® Mini Fluid Collection Bag with Wick, Bag: 9 x 16cm (3 ½ x 6 ¼ in) 100ml Wick: .40 x 15cm (5/32 x 5 7/8 in)
BVI Visidrape® Non-Woven Full Body Incise Drape with Channel Bag 165 x 254cm (65 x 100 in)
BVI Visidrape® Embossed Plastic Aperture Drape with Fluid Collection Bag 101.5 x 127cm (40 x 50 in)
BVI Visidrape® Non-Woven Half Body Incise Drape with Channel Bag 165 x 183cm (65 x 72 in)
BVI Visitec® Microsurgical Accessory Kit
BVI Visidrape® Full Body Incise Drape 140 x 244cm (55 x 96 in)
BVI Visitec® Fluid Collection Bag 17 x 16cm (6 ¾ x 6 ¼ in) 250 ml
BVI POUCH & WICK 100ml STX20 (Equip covers & Accessories)
BVI Visidrape® Non-Woven Aperture Drape with Fluid Collection Bag 101.5 x 127cm (40 x 50 in)
BVI 40x40cm PLASTIC APER STX10
BVI Visidrape® Full Body Aperture Drape 140 x 244cm (55 x 96 in)
BVI Visidrape® Non-Woven Half Body Aperture Drape with Channel Bag 165 x 183cm (65 x 72 in)
BVI Visitec® Ophthalmic Surgery Kit
BVI Visidrape® Incise 10.2 x 20.4cm (4 x 8 in)
BVI Visidrape® Dual Refractive Drape 40 x 26cm (16 x 10 ¼ in)
BVI Visidrape® Non-Woven Aperture Drape with Channel Bag 140 x 127cm (55 x 50 in)
BVI Visidrape® Mini Plastic Incise Drape 41 x 41cm (16 x 16 in)
BVI Visidrape® SMS Incise Drape with Pre-Slit 40 x 40cm (15.75 x 15.75 in)
BVI Visitec® Fluid Collection Bag with Wick, Bag: 17 x 16cm (6 ¾ x 6 ¼ in) 250ml, Wick: .40 x 15cm (5/32 x 5 7/8 in)
BVI 100x127cm PLS OPHTH STX10 (drape)
BVI NW INCISE STX10 (drape)
BVI VISIFLEX INCISE STX10
BVI 127x140cm Aperture drape STx10
BVI 160x180cm HALF BODY STX40 (drape)
BVI 40x40cm PLASTIC INC STX10
BVI Fluid collection bag 17x16cm STX20 (Equip covers & Accessories)
BVI 100x127cm Aperture drape STx10
EYE DRAPE
BVI POUCH & WICK 250ml STX20 E99
BVI 140x244cm FULL BODY STX10
BVI 140x244cm Aperture drape STx10
BVI 40x40cm INCISE DRAPE STX10
BVI 160x250cm FULL BODY STX40 (drape)
BVI 100x127cm PLS APER STX10 (drape)
BVI Dual Refractive drape STx10
MICRO FLOW, BVI, Beaver-Visitec International
Micro Flow Pre-loaded Punctal Occluder
Micro Flow Punctal Occluder
Extend 180 Synthetic Implants (0.4mm x 2mm)
Extend 180 Synthetic Implants 1 Pair (0.3mm x 2mm)
Extend 180 Synthetic Implants 1 Pair (0.5mm x 2mm)
Extend 180 Synthetic Implants (0.5mm x 2mm)
Extend 180 Synthetic Implants Variety Pack
Extend 180 Synthetic Implants 10 Pairs (0.3mm x 2mm)
Y Shape Corneal Marker
Horizontal Axis Marker
Toric Marker
Double-Ring Corneal Marker
Visitec® Visimark Corneal Marking Pad
Mendez Gauge
S Marker
Collagen Temporary Implants 0.3mm x 2mm
Collagen Temporary Implants 0.4mm x 2mm
Collagen Implants Variety Pack
Collagen Temporary Implants 0.2mm x 2mm
Beaver Myringotomy Blade
Beaver Myringotomy Knife
Wet-Field® Eraser® 20-23 GA Tapered Blunt Tip Straight
Wet-Field ® Eraser® 25 GA Fine Tip Straight
Wet-Field® Eraser®, 20GA Blunt Tip 135 Degree
Wet-Field® Eraser®, 20GA Blunt Tip Straight
Wet-Field® Eraser®, 23GA Blunt Tip 135 Degree
Wet-Field ® Eraser® 23 GA Fine Tip Straight
Wet-Field® Eraser® 20-23 GA Tapered Fine Tip Straight
Wet-Field ® Eraser® 25 GA Fine Tip 150 Degree
Wet-Field ® Eraser®, 18GA Bevel Tip
Wet-Field® Eraser®, 20GA Blunt Tip 150 Degree
Wet-Field ® Eraser® 25 GA Fine Tip 135 Degree
Wet-Field® Osher ThermoDot® Marker 25GA fine tip
Wet-Field ® Eraser® 23 GA Fine Tip 150 Degree
Wet-Field ® Eraser® 23 GA Fine Tip 135 Degree
Wet-Field® Eraser®, 23GA Blunt Tip Straight
Wet-Field® Eraser®, 18GA Blunt Tip 45 Degree
Wet-Field® Single Use Bipolar Cable
Extend Synthetic Implants (0.5mm x 2mm)
Extend Synthetic Implants (0.4mm x 2mm)
Extend Synthetic Implants (0.3mm x 2mm)
Extend Synthetic Implants (Variety Pack)
Extend Synthetic Implants (0.2mm x 2mm)
Accu-Temp High Temperature Cautery
Accu-Temp Low Temperature Cautery
BVI Ophthalmic Cannula
Bishop Harmon Cannula
Small Incision Irrigating Vectis
Transcleral Drainage Cannula
LASIK Flap Irrigator
Posterior Scraper
Cortex Extractor
ViscoExpression Cannula
Visitec Nucleus Hydrodissector
Irrigating Cannulas
Infusion Cannulas
LASIK Flap Spatula/Irrigator
Anterior Chamber Cannula
Anterior Chamber Cannula [Rycroft]
Silicone Oil Removal Cannula
Micro Irrigating Vectis
Tapered Hydrodelineator
Membrane Micropick
Visitec Irrigation Handle
50 Cannula
Viscoflow® Cannula
High Viscosity Injector
I and A Cannula
Vitreoretinal Brush
LASIK Cannula
Lacrimal Cannula
Coaxial I and A Cannula
Leatherbarrow Pellet Insertion Cannula 5 SP
Vitreoretinal Cannula
Capsule Polisher
HydroExpression Cannula
Sub-Tenons Anesthesia Cannula
Micro J Shape Hydrodissector
Subretinal Injector
FLACS Cannula
J Shape Cannula
Olive Tip Cannula
LASEK Cannula
Nucleus Hydrodissector
LASIK Irrigating Cannula
Subretinal Fluid Cannula
Micro J Shape Cannula
Soft Tip Cannula
Irrigating Vectis
Cortical Cleaving Hydrodissector
Olive Tip Polisher
Flexible Tip Cannula
Bimanual Irrigation Cannula
Beaver®Tonsillectomy Blade
Beaver®Cataract Blade
Beaver® Neuro-Sharp Blade
Beaver® Lamellar Blade
Beaver® Slit Blade
Beaver® Beaverguard Blade
Beaver Sclerotome Blade
Beaver® Debakey Blade
Beaver® Micro-Blade
Beaver® Sickle Edge Blade
Beaver Pocket Blade
Beaver Mini-Blades
Deluxe Patient Pack
Standard Patient Pack
Canaliculus Intubation Set (CIS) 15.5 cm long
Guibor Canaliculus Intubation Set (CIS)
Beaver Artho-Lok Mini-Banana Blade
Beaver Artho-Lok Mini-Meniscus Blade
Beaver Artho-Lok Round Tip Blade
Beaver Arthro-Lok Pointed Tip Curve Blade
Beaver Artho-Lok Mini-Meniscus Blade (Flat)
Beaver Artho-Lok Blade Hoe Blade
Beaver Arthro-Lok Pointed Retrograde Blade
Beaver Artho-Lok Round Tip (Flat)
Beaver Artho-Lok Retrograde Blade
Beaver Artho-Lok Banana Blade
Visitec Aspirating syringe
EdgeAhead® Sideport MVR Knife
Beaver Mini-Blade®
Atomic Edge® Knife
Visitec® EdgeAhead® Knife
Beaver Sideport MVR Knife
Beaver Xstar® Knives
Beaver Micro-Sharp® Blade
Beaver Micro-Unitome Knife
Beaver Xstar® Slit Knife
Beaver Needle Blade
BeaverGuard Guarded Blade
Beaver Micro Knife
Beaver Optimum Knife
Beaver® Xstar® Safety Slit Knife
Beaver® Swivel Fixation Ring 13mm
Beaver Tympanoplasty Blade
Beaver Sickle Edge Blade
Peribulbar
Retrobulbar
Corneal Trephine
Beaver Iowa P.K. Press Cutting Block
Beaver Replacement Teflon Block
Beaver Iowa P.K. Press
Beaver Troutman Corneal Punch Piston
Lacrimal Trephine
Establishment Types
Export Device to the United States But Perform No Other Operation on Device