Data / Medical devices / Spain / Cydonia Pharma SL
Cydonia Pharma SL: FDA-registered device maker in valencia Valencia(Province), Spain, 51 510(k) clearances
Cydonia Pharma SL is registered with the FDA (registration 3011088743) in valencia Valencia(Province), Spain. It lists 33 device types. The FDA files 51 510(k) clearances under its listings, the newest dated July 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011088743
- Address
- C/Conde Altea 54 p1, valencia Valencia(Province), Spain, 46005
- Owner or operator
- Cydonia Pharma SL (10052225)
- Roles
- Exporter to the US
- First device listed
- June 30, 2016
- Registered through
- 2026
- Brand names listed
- Angiocath IV Catheter; Autoguard IV Catheter; Insyte Autoguard IV Catheter, BD BLOOD LANCET; MULTIPLE LANCETS; MICRO-FINE LANCETS, BD Blood Collection Set, BD Blunt Filter Needle, BD Blunt Filter Needle; BD Visitec Fluid Filter, BD Luer-Lok Access Device, BD Push Button Blood Collection Set, BD Safety-Lok Blood Collection Set 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 |
|---|---|---|---|---|---|---|
| July 21, 2023 | K221327 | BD Alaris Pump Infusion Sets | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| March 24, 2023 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 10, 2023 | K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 11, 2022 | K222744 | Sol-M Luer Lock Syringe | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| May 4, 2022 | K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter | DQY | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 4, 2022 | K212724 | BD Vacutainer UltraTouch Push Button Blood Collection Set | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 6, 2020 | K191915 | SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| April 10, 2019 | K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator | SCL | Substantially Equivalent | Allergy & Applicator Depot, LLC | accessdata.fda.gov |
| March 20, 2019 | K183399 | BD Nexiva Closed IV Catheter System | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| May 25, 2018 | K180111 | ClearGuard HD Antimicrobial Barrier Cap | PEH | Substantially Equivalent | Pursuit Vascular, Inc. | accessdata.fda.gov |
| September 14, 2017 | K171953 | Bard Mission Disposable Core Biopsy Instrument | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| December 19, 2016 | K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 17, 2016 | K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| September 4, 2014 | K141719 | BIOGEL PL MICRO SURGICAL GLOVE | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| February 21, 2014 | K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| March 15, 2012 | K120660 | CONQUEST 40 PTA DILATATION CATHETER | LIT | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| March 14, 2012 | K113700 | VIAVALVE SAFETY IV CATHETER | FOZ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| September 29, 2011 | K111878 | PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 3, 2010 | K101180 | GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, | FPA | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| December 14, 2007 | K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS | LJT | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| November 1, 2007 | K072059 | GRIPPER MICRO NEEDLE | FMI | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| September 10, 2007 | K071565 | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| August 2, 2007 | K071785 | HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE | FMI | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| May 12, 2005 | K050600 | MINILOC SAFETY INFUSION SET | FPA | Substantially Equivalent | Specialized Health Products, Intl. | accessdata.fda.gov |
| July 28, 2004 | K041399 | HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE | FMI | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| February 27, 2004 | K032843 | NEXIVA CLOSED IV CATHETER SYSTEM | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| December 17, 2003 | K033666 | HEMADERM | QSY | Substantially Equivalent | Medafor, Inc. | accessdata.fda.gov |
| November 28, 2003 | K032716 | PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) | CAH | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| May 8, 2003 | K030573 | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 | JKA | Substantially Equivalent | Bd Vacutainer Systems Preanalyical Solutions | accessdata.fda.gov |
| August 13, 2002 | K021999 | GRIPPER PLUS NEEDLE | FPA | Substantially Equivalent | Deltec, Inc. | accessdata.fda.gov |
| April 16, 2002 | K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 | FPA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| October 25, 2001 | K012736 | MONOJECT SAFETY NEEDLE | FMI | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| August 14, 2001 | K011721 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| December 5, 2000 | K002768 | ACAPELLA | BWF | Substantially Equivalent | Dhd Healthcare Corp. | accessdata.fda.gov |
| October 1, 1999 | K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 20, 1999 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | Substantially Equivalent | Johnson & Johnson Medical, Div. of Ethicon, Inc. | accessdata.fda.gov |
| May 28, 1999 | K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| April 9, 1997 | K970796 | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES | DRX | Substantially Equivalent | 3M Healthcare | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 31, 1995 | K952861 | ANGIOCATH & INSYTE AUTOGUARD CATHETERS | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, Inc. | accessdata.fda.gov |
| January 18, 1995 | K945952 | VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 16, 1994 | K942061 | DISPOSABLE SUCTION PROBE | JOL | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| March 22, 1994 | K936194 | COAXIAL BIOPSY NEEDLE | FCG | Substantially Equivalent | Bard Gynecology and Radiology | accessdata.fda.gov |
| February 14, 1994 | K933751 | LIFESHIELD BLOOD COLLECTION DEVICE | FMI | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| November 25, 1992 | K922522 | MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| September 1, 1992 | K923090 | SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD | JKA | Substantially Equivalent | Ryan Medical, Inc. | accessdata.fda.gov |
| October 23, 1991 | K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| March 29, 1983 | K830710 | ARGYLE SILICONE SALEM SUMP TUBE | KNT | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| June 20, 1980 | K801343 | B-D FILTER NEEDLE | FPB | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| April 4, 1979 | K790366 | URINE CULTURE KIT | JTW | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
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Updated July 21, 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.