Data / Medical devices / Belgium / Palm Medical International BV
Palm Medical International BV: FDA-registered device maker in Buggenhout Oost-Vlaanderen, Belgium, 68 510(k) clearances
Palm Medical International BV is registered with the FDA (registration 3030626857) in Buggenhout Oost-Vlaanderen, Belgium. It lists 46 device types. The FDA files 68 510(k) clearances under its listings, the newest dated March 24, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3030626857
- Address
- Broekstraat 65, Buggenhout Oost-Vlaanderen, Belgium, 9255
- Owner or operator
- PALM MEDICAL INTERNATIONAL BV (10090320)
- Roles
- Exporter to the US
- First device listed
- March 12, 2024
- Registered through
- 2027
- Brand names listed
- APPARATUS, SUCTION, PATIENT CARE, Anesthesia conduction kit, Anti fog solution and accessories, endoscopy GCJ - Laparoscope, general & plastic surgery, Biopsy needle, CONTAINER, LIQUID MEDICATION, GRADUATED, CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE, Catheter, intravascular, therapeutic, short-term less than 30 days, Electrosurgical, cutting & coagulation & accessories 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 |
|---|---|---|---|---|---|---|
| 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 |
| September 23, 2022 | K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228 | JOJ | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| June 28, 2022 | K211705 | 3M Attest Rapid Readout Biological Indicator, 1295 | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| June 24, 2022 | K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | JOJ | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| May 23, 2022 | K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 | JOJ | Substantially Equivalent | 3M Company | 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 |
| October 21, 2020 | K201155 | PleurX Peritoneal Catheter System | PNG | Unknown | Care Fusion | 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 |
| November 30, 2018 | K181221 | BD PhaSeal Optima Closed System Transfer Device | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 22, 2018 | K173584 | 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| August 10, 2017 | K171116 | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | MSH | Substantially Equivalent | 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 |
| October 31, 2016 | K160450 | Pleurx Pleural Catheter System | DWM | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| September 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | 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 |
| September 19, 2014 | K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | FPA | Substantially Equivalent | Acacia, Inc. | 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 |
| January 9, 2013 | K123213 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE | ONB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 30, 2012 | K120412 | 3M SPOTON TEMPERATURE MONITORING SYSTEM | FLL | Substantially Equivalent | Arizant Healthcare, Inc. | accessdata.fda.gov |
| March 23, 2012 | K120743 | SPECULUM, VAGINAL, NONMETAL | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| March 19, 2012 | K113854 | PLEURX PERITONEAL CATHETER SYSTEM | PNG | Unknown | Care Fusion | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 6, 2011 | K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| September 8, 2010 | K101249 | STERIGAGE MODEL 1243RA, 1243RB, 1243RE | JOJ | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| December 7, 2009 | K092782 | INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, | LHI | Substantially Equivalent | Carmel Pharma Ab. | accessdata.fda.gov |
| October 9, 2009 | K091758 | BD SPINAL NEEDLE 27G | BSP | Substantially Equivalent | Becton Dickson & Co. | accessdata.fda.gov |
| April 29, 2009 | K090569 | MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| March 23, 2009 | K090634 | PHASEAL PROTECTOR P14, P21, P28 AND P50 | LHI | Substantially Equivalent | Carmel Pharma Ab. | accessdata.fda.gov |
| July 17, 2008 | K081446 | BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 | BSP | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| October 5, 2006 | K062779 | DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) | GCJ | Substantially Equivalent | New Wave Surgical Corporation | accessdata.fda.gov |
| June 16, 2005 | K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| May 12, 2005 | K050600 | MINILOC SAFETY INFUSION SET | FPA | Substantially Equivalent | Specialized Health Products, Intl. | accessdata.fda.gov |
| February 22, 2005 | K050159 | MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 | DQD | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| February 27, 2004 | K032843 | NEXIVA CLOSED IV CATHETER SYSTEM | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | 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 |
| August 28, 2002 | K020785 | INTROCAN SAFETY IV CATHETER | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | 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 |
| 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 |
| June 13, 2001 | K011103 | BD SPRING BASED SYRINGE | MEG | Substantially Equivalent | Bd | accessdata.fda.gov |
| March 1, 2001 | K010188 | BD ECLIPSE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Bd Medical Systems | accessdata.fda.gov |
| January 27, 2000 | K993848 | MILLENNIUM HUBER PLUS SAFETY INFUSION SET | FPA | Substantially Equivalent | Millennium Medical Distribution, Inc. | accessdata.fda.gov |
| October 1, 1999 | K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| June 16, 1999 | K991406 | TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER | FOZ | Substantially Equivalent | Terumo Medical Corp. | 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 |
| October 28, 1998 | K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | FMI | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| April 30, 1998 | K973741 | BAIR HUGGER BLOOD/FLUID WARMER | BSB | Substantially Equivalent | Augustine Medical, Inc. | accessdata.fda.gov |
| October 4, 1996 | K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| November 30, 1995 | K953790 | BD PERISAFE EPIDURAL ANESTHESIA TRAY | CAZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | 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 |
| July 10, 1995 | K952578 | WELCH ALLY OTOSCOPE | ERA | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| April 18, 1995 | K950301 | ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, Inc. | accessdata.fda.gov |
| April 4, 1995 | K950461 | WELCH ALLYN OPHTHALMOSCOPE | HLI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| January 13, 1995 | K945513 | MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| January 11, 1995 | K944757 | PISTON SYRINGES | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 30, 1994 | K940697 | BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK | FPA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 26, 1994 | K941562 | 1ML LUER-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 7, 1994 | K934370 | BIP BIOPSY NEEDLE MODIFICATION | FCG | Substantially Equivalent | Bip USA, Inc. | accessdata.fda.gov |
| January 14, 1993 | K925902 | B-D LOSS OF RESISTANCE SYRINGE | CAZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 6, 1992 | K914190 | AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR | GAD | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| July 3, 1990 | K900771 | ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| October 2, 1986 | K863330 | DISPOSABLE PNEUMOPERITONEUM NEEDLE | FHO | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| September 17, 1981 | K801550 | 3M GERMICIDAL SURGICAL INCISE DRAPE | KKX | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| June 26, 1981 | K811447 | SHILEY DISPOSABLE CANNULA TRACH. TUBE | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
Compare with other makers
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- All makers of Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- All makers of Ophthalmoscope, Ac-Powered
- All makers of Needle, Hypodermic, Single Lumen
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.