Data / Medical devices / Bulgaria / Saint Jones Management LP Eood
Saint Jones Management LP Eood: FDA-registered device maker in Sofia Sofia-Grad, Bulgaria, 64 510(k) clearances
Saint Jones Management LP Eood is registered with the FDA (registration 3016904853) in Sofia Sofia-Grad, Bulgaria. It lists 68 device types. The FDA files 64 510(k) clearances under its listings, the newest dated March 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016904853
- Address
- Stefan Kirov 42, Sofia Sofia-Grad, Bulgaria, 1111
- Owner or operator
- Saint Jones Management LP EOOD (10074449)
- Roles
- Exporter to the US, Remanufacturer, Repackager or relabeler
- First device listed
- May 24, 2020
- Registered through
- 2026
- Brand names listed
- SAINT JONES
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 |
|---|---|---|---|---|---|---|
| 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 |
| December 7, 2022 | K213919 | Dexcom G7 Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| May 19, 2022 | K210983 | BD Epilor Syringe | CAZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 31, 2022 | K220584 | BD Cathena Safety IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| December 18, 2020 | K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter | FOZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 27, 2019 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | Substantially Equivalent | ETHICON, Inc. | 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 |
| April 19, 2018 | K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | FMI | Substantially Equivalent | Greiner Bio-One Na, Inc. | accessdata.fda.gov |
| November 21, 2017 | K170754 | 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing | FRO | Substantially Equivalent | 3M Company, 3M Healthcare | 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 |
| November 30, 2016 | K162450 | ESPADA Acne-Clearing Blue Light Pen | OLP | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| October 19, 2016 | K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad | OMP | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| November 13, 2015 | K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | HIH | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| July 27, 2015 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| February 12, 2014 | K130040 | MEPITEL AG | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| April 4, 2013 | K123507 | KCI NPWT GAUZE DRESSING | OMP | Substantially Equivalent | Kci USA, Inc. | accessdata.fda.gov |
| October 18, 2011 | K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| March 25, 2011 | K103551 | INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| September 15, 2010 | K100029 | MEPILEX BORDER AG DRESSING | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| March 30, 2010 | K100559 | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | HIH | Substantially Equivalent | Interlace Medical, Inc. | accessdata.fda.gov |
| December 18, 2007 | K070060 | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| September 14, 2007 | K072320 | GREINER VACUETTE QUICKSHIELD COMPLETE | FMI | Substantially Equivalent | Greiner Bio-One North America, Inc. | accessdata.fda.gov |
| May 18, 2007 | K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| March 16, 2007 | K070440 | BD HYPOINT NEEDLE | FMI | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| April 10, 2006 | K053441 | BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 10, 2006 | K053102 | BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| February 1, 2006 | K053443 | BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 16, 2005 | K050184 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 10, 2004 | K033880 | ELECTRO-LUBE | GEI | Substantially Equivalent | Mectra Labs, Inc. | accessdata.fda.gov |
| December 29, 2003 | K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | FMI | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| December 5, 2003 | K032821 | HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF | NPP | Substantially Equivalent | Hygia Health Services, Inc. | accessdata.fda.gov |
| August 27, 2003 | K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA | BTO | 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 |
| May 6, 2003 | K030580 | SURETEMP PLUS | FLL | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| February 3, 2003 | K022483 | ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING | FRO | Substantially Equivalent | Johnson & Johnson Medical, Ltd. | accessdata.fda.gov |
| January 27, 2003 | K023971 | VACUETTE TRACE ELEMENTS TUBES | JKA | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | 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 |
| February 14, 2002 | K014129 | PROMOGRAN MATRIX WOUND DRESSING | KGN | Substantially Equivalent | Johnson & Johnson Medical, Ltd. | accessdata.fda.gov |
| December 21, 2001 | K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| August 17, 2001 | K012455 | WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| July 12, 2001 | K011786 | VACUETTE SAFETY BLOOD COLLECTION SET | FMI | Substantially Equivalent | Greiner Vacuette North America, Inc. | accessdata.fda.gov |
| June 28, 2001 | K011699 | VACUETTE EVACUATED BLOOD COLLECTION TUBES | JKA | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| June 13, 2001 | K011103 | BD SPRING BASED SYRINGE | MEG | Substantially Equivalent | Bd | accessdata.fda.gov |
| August 14, 2000 | K000421 | BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE | KGO | Substantially Equivalent | Ssl Americas, Inc. (Regent Medical) | accessdata.fda.gov |
| October 1, 1999 | K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 26, 1999 | K972615 | CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 8, 1998 | K972184 | RUSCH BRILLANT SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | Rusch Intl. | accessdata.fda.gov |
| November 7, 1997 | K973301 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE | MEG | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| December 23, 1996 | K960492 | SI CONTROLLER MODEL SI 500 | BTA | Substantially Equivalent | I.C Medical, Inc. | accessdata.fda.gov |
| August 30, 1996 | K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| June 21, 1996 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| June 12, 1995 | K952084 | HUMID-VENT FILTER PEDI | BYD | Substantially Equivalent | Gibeck, 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 |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 19, 1994 | K941932 | SPLASH MASK | LYU | Substantially Equivalent | Incon Diversified Industries, Inc. | accessdata.fda.gov |
| May 26, 1994 | K941562 | 1ML LUER-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| February 25, 1994 | K925791 | EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR | FLL | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| January 13, 1989 | K884421 | PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT | DXQ | Substantially Equivalent | Pymah Corp. | accessdata.fda.gov |
| July 23, 1985 | K852211 | OPSITE WOUND DRESSING | NAD | Substantially Equivalent for Some Indications | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 12, 1984 | K833916 | HYPAFIX DRESSING RETENTION SHEET | KGX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 20, 1980 | K801343 | B-D FILTER NEEDLE | FPB | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
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Updated March 24, 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.