FDA Registration
Active
🇲🇽 Mexico
AvailMed S.A.De C.V.
Reg #: 3010291427
·
FEI: 3010291427
·
Expires 2026
Products
49
Proprietary Names
136
Establishment Types
2
Classifications
49
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Registration Details
- Registration Name
- AvailMed S.A.De C.V.
- Registration Number
- 3010291427
- FEI Number
- 3010291427
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- C.Industrial Lt.001 Mz.105, No. 20905 Int.A. Col. Cd. Industrial
- City
- Tijuana Baja California
- Country
- MX
Owner / Operator
- Firm Name
- Flextronics International USA, Inc.
- Operator Number
- 9006592
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- Postal Code
- 78759
- Country
- US
- Correspondent
- Chad Ashton
US Agent
- Business Name
- FLEXTRONICS INTERNATIONAL USA, INC.
- Contact Name
- Chad Ashton
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- ZIP
- 78759
- Country
- US
- [email protected]
- Phone
- 901 8712423
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2009-10-22 |
| Ophthalmic Femtosecond Laser | OOE | Class 2 | Ophthalmic | No | 2023-04-28 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2017-05-04 |
| Stimulator, Low Electric Field, Tumor Treatment | NZK | Class 3 | Unknown | No | 2023-12-15 |
| Adaptor, Ureteral Catheter | EYI | Class 1 | Gastroenterology, Urology | No | 2026-01-23 |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | Class 2 | Clinical Chemistry | No | 2025-08-19 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2017-01-31 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2012-12-19 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2013-11-26 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2014-05-13 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2012-05-28 |
| Sealant, Dural | NQR | Class 3 | Unknown | No | 2017-06-15 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2009-10-22 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2026-05-14 |
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2009-10-22 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2009-10-22 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2010-08-04 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2009-10-22 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2014-01-23 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2010-07-15 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2017-05-04 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2022-04-27 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2009-10-21 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2018-04-20 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2011-09-21 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2014-05-13 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2017-01-31 |
| Catheter, Retention, Barium Enema With Bag | FGD | Class 2 | Gastroenterology, Urology | No | 2015-01-08 |
| Urinal | FNP | Class 1 | General Hospital | No | 2015-07-05 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2016-11-14 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2014-02-28 |
| Automated Insulin Dosing , Threshold Suspend | OZO | Class 3 | Unknown | No | 2020-02-25 |
| Sensor, Glucose, Invasive, Non-Adjunctive | PQF | Class 3 | Unknown | No | 2020-02-25 |
| Catheter, Retention Type | EZK | Class 2 | Gastroenterology, Urology | No | 2009-10-22 |
| Vitrectomy, Instrument Cutter | MLZ | Class 2 | Ophthalmic | No | 2017-05-04 |
| System/Device, Pharmacy Compounding | NEP | Class 2 | General Hospital | No | 2017-01-23 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2016-03-31 |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | Class 1 | Obstetrics/Gynecology | No | 2009-12-17 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2017-01-13 |
| Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | QON | Class 3 | Gastroenterology, Urology | No | 2014-07-30 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2026-06-05 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2009-10-22 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2009-10-22 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2019-12-20 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2014-03-01 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2015-09-17 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2015-07-05 |
| Stimulator, Electrical, Implantable, For Incontinence | EZW | Class 3 | Gastroenterology, Urology | No | 2014-07-30 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2024-11-06 |
Proprietary Names
MEDRAD INTEGO STERILE DISPOSABLES
Ophthalmic Femtosecond Laser
Single Use Pack, Model OPO80
FUSION OPO70 Pack
FUSION OPO71 DUAL PUMP Pack
Optune
Sterile Luer Lock-to-Urethral Tip Adapter
Mobi, 10 Pack
RapidFill Connectors
Dispensing Pin
Tube Set
PEAK PlasmaBlade Suction Coag Model Number PS300-004E
Runway Guide Catheter
Hemostatic Valve, .115 ID SKU 23245
Y-Connector with modified Tuohy-Borst Adapter, Stretch insertion tool
OPOHF20L, 20G High Flow Irrigation Sleeve, Reusable
OPOHF21L, 21G High Flow Irrigation Sleeve, Reusable
Sealant, Dural
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
InfoVAC Canisters, V.A.C Freedom Canisters
LEAD STYLET,MODELS 6505,6506,6507,6508
INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE, INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, 6400, 1001-22
Piton Y-adapter, Piton Tri-adapter
Mullins Transseptal Catheter Introducer Sheath and Medtronic Transseptal Catheter Introducer Sheath
MODIFICATION TO SCIMED 6F IMPULSE A
SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATER
ABTHERA Open Abdomen Dressing
034-SKR-421, 034-SKR-420-4
STRYKER PAINPUMP PCA
CYSTO-AID
130 CM WIDE
Guide Wire Introducer SKU 22290
Guide Wire Accessory Kit SKU 22295
Torque Device SKU 22215; 1003279
Guide Wire Accessory Kit w/115 RHV; SKU 22295-115
Torque Device SKU 22215
Unit, phacofragmentation
Impulse Angiographic Catheter
Expo Angiographic Catheter
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
V.A.C Y-connector
SCIMED IMPULSE ANGIOGRAPHIC CATHETE
SCIMED IMPULSE ANGIOGRAPHIC CATHETER
OPO39, AMO VitrePure Vitretomy Handpiece
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
Everest 20/30 Inflation Device, Everest 20/30 Survival Kit
ExactaMix Bag
Universal Spike
HyHub Vial Access Devices
REPEATER PUMP II TUBE SETS
ActiVAC Canisters
Stryker Color Cuff Cylindrical Tourniquet
OPOD20L, 20G Laminar Flow Irrigation Sleeve
Indeflator Plus 30 SKU 1000183
Priority Pack Plus 30 w/115 RHV; SKU 1000185-115
Priority Pack Plus 30 SKU 1000185
Priority Pack 20/30 w/ CoPilot; SKU 1003327
Guide Wire Accessory Kit w/ CoPilot; SKU 1003330
Copilot BBC Valve SKU 1003331
EXACTAMIX Bag Cap
ExactaMed
Tip Cap
DiscPac Tip Cap
Adapter Connector
PTCA Accessory Pack (Y-Adaptor with Hemostasis Valve, Stretch Insertion Tool)
Priority Pack 20/30 SKU 1000186
Indeflator 20/30 SKU 1000184
Priority Pack 20/30 w/115 RHV; SKU 1000186-115
CATHETER, RETENTION, BARIUM ENEMA WITH BAG, 1001-21, Exacta-I screw cap
CATHETER RETENTION BARIUM WITH BAG, Flexi-Tip, 1001-30, 1001-32, 1001-36
Barium Enema Ring, 1001-20
CATHETER RETENTION BARIUM WITH BAG, RTB BULK PACK,1001-1 SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF, 1001-11
Rounded Flex-Tip, 1001-28
CATHETER RETENTION BARIUM WITH BAG, NS TUBING CLAMP, EZEM-848
CATHETER RETENTION BARIUM WITH BAG,AIR BULB INSUFLATOR,1001-37,ONE SHOT CUFF INFLATOR 1001-38, XL MILLER AIRTIP,1001-84
Non Latex, air retention tip, 1001-025
Enema delivery system
CATHETER, INTRAVASCULAR, Catheter, percutaneous
V390 Cysto Aid, BCC-1001-093
AbThera SensaT.R.A.C. Open Abdomen Dressing, AbThera Advance Open Abdomen Dressing
PI's
Endopouch Retriever
SCIMED EXPO ANGIOGRAPHIC CATHETER
Needle Adapter
t:slim X2 Insulin Pump with Basal-IQ Technology
E-Z-EM Enteroclysis Catheter Set, ET 412
E-Z-EM Enteroclysis Catheter Set
Stryker Laparoscope
NGP0020, Vitreous Cutter 25G
NGP0020, Vitreous Cutter 20G
NGP0020, Vitreous Cutter 23G
V.A.C Drape, V.A.C Tubing Cap, Sensatrac pad
OPOS19L, 19G Laminar Flow Irrigation Sleeve, Reusable
OPOS21LD, 21G Laminar Flow Irrigation Sleeve
OPOS21L, 21G Laminar Flow Irrigation Sleeve, Reusable
OM3452032, OMS Infusion Sleeve, Reusable
OPOS20LD, 20G Laminar Flow Irrigation Sleeve
OPOS20L, 20G Laminar Flow Irrigation Sleeve, Reusable
OM5240011, Aspirant Collection Bag
OM3452022, Phacotest Chamber, Reusable
Dual Pump Pack, Model OPO73
SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER
Rotating Hemostatic Valve SKU 23242
ExactaMix Valve Set
SONO-VU US
SOVERIGN Compact/DIPLOMAX II Reusable Pack, Model OPO65
SOVERIGN Compact/DIPLOMAX II Pack, Model OPO61
Syringe Balloon,Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Kit
InterStim Therapy System And Verify Evaluation System. Cable (6pk), Model 357506
PEAK PlasmaBlade TnA Model Number PS300-002
PEAK PlasmaBlade Adenoid Model Number PS300-003
PEAK PlasmaBlade Tonsil Model Number PS300-001
PEAK PlasmaBlade TnA Model Number PS300-002E
PEAK PlasmaBlade Tonsil Model Number PS300-001E
PEAK PlasmaBlade Adenoid Model Number PS300-003E
Catheter, Intravascular, diagnostic, Impulse Angiographic, Expo Angiographic catheter
DuraSeal Exact Spine Sealant System
Multiple-Use Pack, Model OPO85
Optune Gio
SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
V.A.C. ABDOMINAL DRESSING
DxTerity Catheter
PERCUGUIDE Lesion Marking
Boston Scientific 5F, 7F, and 8F Mach1 Guide Catheters
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
CeQur Simplicity
Needle, aspiration and injection, reusable
BONE BIOPSY NEEDLE; CHIBA NEEDLE; PERCUCUT NEEDLES, N105, N110, N115, N710, N715, N810. N815
BD NEEDLE,25GX7/8, BD NEEDLE,20GX1-1/2
J-VAC Suction Reservoir
763 Measuring Device, BCC-EZEM-763
722 Mixing Container, BCC-EZEM-722
V.A.C. Granufoam Dressings, V.A.C. Granufoam Bridge and Bridge XG Dressings, V.A.C. Simplace and Simplace Ex Dressings
InterStim Therapy System And Verify Evaluation System. Cable (1pk), Model 357501
SC+ Hemodialysis Machine
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device