Availmed S A De C V

FDA Filings

This page includes the latest FDA filings for Availmed S A De C V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010291427
FEI Number3010291427
NameAvailMed S.A.De C.V.
Owner & OperatorFlextronics International USA, Inc.
Contact Address6201 America Center Drive ATT: Rachael Serafini
San Jose CA 95002 US
Official Correspondent
  • Daniel - Mcminn
  • 1-669-2631956-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressC.Industrial Lt.001 Mz.105 No. 20905 Int.A. Col. Cd. Industrial
Tijuana Baja California, C.P. 22444 MX
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
t:slim X2 Insulin Pump with Basal-IQ Technology2020-02-25
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
t:slim X2 Insulin Pump with Basal-IQ Technology2020-02-25
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
REPEATER PUMP II TUBE SETS2018-04-20
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
DuraSeal Exact Spine Sealant System2017-10-19
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Sealant, Dural2017-06-15
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OPO39, AMO VitrePure Vitretomy Handpiece2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Needle Adapter2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OPOS21LD, 21G Laminar Flow Irrigation Sleeve2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OPOS21L, 21G Laminar Flow Irrigation Sleeve, Reusable2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OPOS20LD, 20G Laminar Flow Irrigation Sleeve2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OPOS20L, 20G Laminar Flow Irrigation Sleeve, Reusable2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OPOS19L, 19G Laminar Flow Irrigation Sleeve, Reusable2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OM5240011, Aspirant Collection Bag2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OM3452032, OMS Infusion Sleeve, Reusable2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OM3452022, Phacotest Chamber, Reusable2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OPOD20L, 20G Laminar Flow Irrigation Sleeve2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Single Use Pack, Model OPO802017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OPOHF21L, 21G High Flow Irrigation Sleeve, Reusable2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
OPOHF20L, 20G High Flow Irrigation Sleeve, Reusable2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
NGP0020, Vitreous Cutter 25G2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
NGP0020, Vitreous Cutter 23G2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
NGP0020, Vitreous Cutter 20G2017-05-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Multiple-Use Pack, Model OPO852017-05-02
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Dual Pump Pack, Model OPO732017-02-07
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Tube Set2017-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
RapidFill Connectors2017-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Dispensing Pin2017-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Tip Cap2017-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
ExactaMed2017-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
EXACTAMIX Bag Cap2017-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
DiscPac Tip Cap2017-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Adapter Connector2017-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
ExactaMix Valve Set2017-01-23
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
ExactaMix Valve Set2017-01-23
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SOVERIGN Compact/DIPLOMAX II Reusable Pack, Model OPO652017-01-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SOVERIGN Compact/DIPLOMAX II Pack, Model OPO612017-01-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PI's2016-11-14
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
FUSION OPO71 DUAL PUMP Pack2016-09-07
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
FUSION OPO70 Pack2016-09-07
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
DxTerity Catheter2016-08-29
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Syringe Balloon,Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Kit2016-05-02
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Catheter, Intravascular, diagnostic, Impulse Angiographic, Expo Angiographic catheter2016-03-15
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM Negative Pressure Wound Therapy Powered Suction Pump2015-11-25
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM2015-11-25
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
J-VAC? Suction Reservoir2015-09-17
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
763 ? Measuring Device, BCC-EZEM-7632015-07-05
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
722 Mixing Container, BCC-EZEM-7222015-07-05
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
V390 Cysto Aid, BCC-1001-0932015-07-05
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Rounded Flex-Tip, 1001-282015-01-08
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Non Latex, air retention tip, 1001-0252015-01-08
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Enema delivery system2015-01-08
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
CATHETER, RETENTION, BARIUM ENEMA WITH BAG, 1001-21, Exacta-I screw cap2015-01-08
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
CATHETER RETENTION BARIUM WITH BAG,AIR BULB INSUFLATOR,1001-37,ONE SHOT CUFF INFLATOR 1001-38, XL MILLER AIRTIP,1001-842015-01-08
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
CATHETER RETENTION BARIUM WITH BAG, RTB BULK PACK,1001-1 SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF, 1001-112015-01-08
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
CATHETER RETENTION BARIUM WITH BAG, NS TUBING CLAMP, EZEM-8482015-01-08
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
CATHETER RETENTION BARIUM WITH BAG, Flexi-Tip, 1001-30, 1001-32, 1001-362015-01-08
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Barium Enema Ring, 1001-202015-01-08
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
InterStim Therapy System And Verify Evaluation System. Cable (1pk), Model 3575012014-07-30
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
InterStim Therapy System And Verify Evaluation System. Cable (6pk), Model 3575062014-07-30
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Priority Pack 20/30 w/ CoPilot; SKU 10033272014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Guide Wire Accessory Kit w/ CoPilot; SKU 10033302014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Copilot BBC Valve SKU 10033312014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Priority Pack Plus 30 w/115 RHV; SKU 1000185-1152014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Priority Pack Plus 30 SKU 10001852014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Indeflator Plus 30 SKU 10001832014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Priority Pack 20/30 w/115 RHV; SKU 1000186-1152014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Priority Pack 20/30 SKU 10001862014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Indeflator 20/30 SKU 10001842014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Torque Device SKU 222152014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Torque Device SKU 22215; 10032792014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Guide Wire Introducer SKU 222902014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Guide Wire Accessory Kit w/115 RHV; SKU 22295-1152014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Guide Wire Accessory Kit SKU 222952014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Torque Device SKU 222152014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Torque Device SKU 22215; 10032792014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Guide Wire Introducer SKU 222902014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Guide Wire Accessory Kit w/115 RHV; SKU 22295-1152014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Guide Wire Accessory Kit SKU 222952014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Hemostatic Valve, .115 ID SKU 232452014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Rotating Hemostatic Valve SKU 232422014-05-13
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Needle, aspiration and injection, reusable2014-03-01
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
BONE BIOPSY NEEDLE; CHIBA NEEDLE; PERCUCUT NEEDLES, N105, N110, N115, N710, N715, N810. N8152014-03-01
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
BD NEEDLE,25GX7/8, BD NEEDLE,20GX1-1/22014-03-01
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Endopouch Retriever2014-02-28
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
CYSTO-AID2014-01-23
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Runway Guide Catheter2013-11-26
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Impulse Angiographic Catheter2013-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Expo Angiographic Catheter2013-01-31
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PEAK PlasmaBlade Suction Coag Model Number PS300-004E2012-12-19
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PEAK PlasmaBlade Tonsil Model Number PS300-001E2012-12-19
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PEAK PlasmaBlade Tonsil Model Number PS300-0012012-12-19
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PEAK PlasmaBlade TnA Model Number PS300-002E2012-12-19
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PEAK PlasmaBlade TnA Model Number PS300-0022012-12-19
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PEAK PlasmaBlade Adenoid Model Number PS300-003E2012-12-19
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PEAK PlasmaBlade Adenoid Model Number PS300-0032012-12-19
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PTCA Accessory Pack (Y-Adaptor with Hemostasis Valve, Stretch Insertion Tool)2012-12-14
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Piton Y-adapter, Piton Tri-adapter2012-05-28
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Y-Connector with modified Tuohy-Borst Adapter, Stretch insertion tool2012-05-28
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Stryker Color Cuff Cylindrical Tourniquet2011-09-21
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Everest 20 Inflation Device, Everest 20 Survival Kit2010-11-11
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Mullins Transseptal Catheter Introducer Sheath and Medtronic Transseptal Catheter Introducer Sheath2010-11-11
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SCIMED EXPO ANGIOGRAPHIC CATHETER2010-08-24
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER2010-08-09
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SCIMED IMPULSE ANGIOGRAPHIC CATHETER2010-08-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SCIMED IMPULSE ANGIOGRAPHIC CATHETE2010-08-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATER2010-08-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
MODIFICATION TO SCIMED 6F IMPULSE A2010-08-04
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Boston Scientific 5F, 7F, and 8F Mach1 Guide Catheters2010-07-30
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Everest 30 Inflation Device, Everest 30 Survival Kit2010-07-27
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
130 CM WIDE2010-07-15
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING2010-07-14
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PREVENA INCISION MANAGEMENT SYSTEM2010-06-15
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SONO-VU US2009-12-17
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
LEAD STYLET,MODELS 6505,6506,6507,65082009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
V.A.C. PLUS2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PERCUGUIDE Lesion Marking2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
E-Z-EM Enteroclysis Catheter Set2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
E-Z-EM Enteroclysis Catheter Set, ET 4122009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Stryker Laparoscope2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
ABTHERA Open Abdomen Dressing2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Avail Sterile, Latex Free, Water Filled Syringe2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
MEDRAD INTEGO STERILE DISPOSABLES2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
INFO VAC Therapy Unit2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
ACTI V.A.C. Therapy Unit Model 34002009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
V.A.C. Therapy System2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE, INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, 6400, 1001-222009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
V.A.C. ABDOMINAL DRESSING2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
STRYKER PAINPUMP PCA2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
034-SKR-421, 034-SKR-420-42009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION2009-10-22
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER2009-10-21
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Steri-Lub(TM) Lubrication Gel2009-10-21
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
CATHETER, INTRAVASCULAR, Catheter, percutaneous2009-10-21
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
CATHETER, INTRAVASCULAR, Catheter, percutaneous2009-10-21
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Unit, phacofragmentation2009-10-21
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Universal Spike2009-10-21
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Tube Set2009-10-21
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
ExactaMix Bag2009-10-21
AvailMed S.A.De C.V. [Flextronics International USA, Inc.]
Steri-Lub(TM) Lubrication Gel Syrin2009-10-21

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