Data / Medical devices / Netherlands / Pharmco Medical BV
Pharmco Medical BV: FDA-registered device maker in ROTTERDAM Zuid-Holland, Netherlands, 117 510(k) clearances
Pharmco Medical BV is registered with the FDA (registration 3030447506) in ROTTERDAM Zuid-Holland, Netherlands. It lists 92 device types. The FDA files 117 510(k) clearances under its listings, the newest dated March 25, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3030447506
- Address
- Albert Plesmanweg 39 X, ROTTERDAM Zuid-Holland, Netherlands, 90477456
- Owner or operator
- PHARMCO MEDICAL BV (10089125)
- Roles
- Exporter to the US
- First device listed
- December 19, 2023
- Registered through
- 2027
- Brand names listed
- BECTON DICKINSON, BIOPSY INSTRUMENT, BIOPSY NEEDLE, CABLE,RD SET, CANNULA, TRACH, CATHETER, URETERAL OPEN END, Catheter, SENSOR, NEONATE 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. Newest 100 of 117.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 25, 2024 | K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | DYB | Substantially Equivalent | Cook Medical | accessdata.fda.gov |
| September 20, 2023 | K230239 | AirSeal iFS System; AirSeal dV Solution | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 27, 2023 | K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 20, 2023 | K222462 | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) | KNW | Substantially Equivalent | Itp Innovative Tomography Products GmbH | accessdata.fda.gov |
| October 28, 2022 | K223098 | Bakri Essential Postpartum Balloon | OQY | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 16, 2022 | K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| February 17, 2022 | K220137 | Lunderquist Extra Stiff Wire Guide | DQX | Substantially Equivalent | William Cook Europe Aps | accessdata.fda.gov |
| September 9, 2021 | K212246 | Exofin Precision Pen | MPN | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| August 19, 2021 | K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 7, 2021 | K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| December 17, 2020 | K200264 | Exofin High Viscosity Topical Skin Adhesive | MPN | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| October 24, 2019 | K181660 | Acapella Choice Blue Vibratory PEP Device | BWF | Substantially Equivalent | Smiths Medical | accessdata.fda.gov |
| July 22, 2019 | K182985 | Roadrunner PC Wire Guide, Olcott Torque Device | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 28, 2019 | K180739 | Clearlink System Solution Set | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| May 17, 2019 | K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | LJE | Unknown | Cook Incorporated | 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 |
| March 13, 2019 | K183600 | Anchor Bag-Alone Tissue Retrieval System by ConMed | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 20, 2018 | K183036 | Dilator Sets | DRE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 30, 2018 | K181221 | BD PhaSeal Optima Closed System Transfer Device | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 23, 2018 | K180046 | Masimo Rad-97 and Accessories | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| September 11, 2018 | K173822 | Anchor Tissue Retrieval System by CONMED | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 4, 2018 | K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 3, 2018 | K172980 | Micropuncture Pedal Access Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 10, 2018 | K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube | BTO | Substantially Equivalent | Smiths Medical Ads, Inc. | accessdata.fda.gov |
| March 9, 2018 | K171764 | Fixed Core Wire Guides | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 27, 2018 | K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S | FGE | Substantially Equivalent | Cook Ireland, Ltd. | accessdata.fda.gov |
| February 1, 2018 | K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter | KOD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 21, 2017 | K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 12, 2017 | K170898 | Wittich Nitinol Stone Basket | LQR | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 7, 2017 | K170720 | Portex Blue Line Ultra Paediatric Tracheosomy Tube | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| November 17, 2017 | K173068 | Performer Introducer | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 15, 2017 | K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 7, 2017 | K173009 | NCompass Nitinol Stone Extractors | LQR | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 18, 2017 | K172940 | ANCHOR Tissue Retrieval System | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 25, 2017 | K171442 | Exofin Fusion Skin Closure System | OMD | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| July 28, 2017 | K171602 | Williams Cystoscopic Injection Needle | FBK | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 17, 2017 | K160200 | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set | BWC | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 19, 2016 | K160007 | Paclitaxel Sets | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 27, 2016 | K160596 | BEAUTIFIL II LS | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| April 8, 2016 | K160223 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter | NHC | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 1, 2016 | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | accessdata.fda.gov |
| February 9, 2016 | K152476 | Exofin High Viscosity Tissue Adhesive | MPN | Substantially Equivalent | Chemence Medical Products, Inc. | accessdata.fda.gov |
| December 28, 2015 | K153158 | Solution Administration Sets with 0.2 Micron Filter | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 24, 2015 | K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 10, 2015 | K150569 | LaparoVue | GCJ | Substantially Equivalent | Buffalo Filter, LLC | accessdata.fda.gov |
| March 20, 2015 | K143404 | SurgiQuest AirSeal iFS System | HIF | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| February 10, 2015 | K142716 | VCARE | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 19, 2014 | K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | MWI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| November 19, 2014 | K142600 | VIAL-MATE Adaptor | LHI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| August 19, 2014 | K140703 | OPA 30 SOLUTION | MED | Substantially Equivalent | Ciden Technologies, LLC | accessdata.fda.gov |
| August 18, 2014 | K142011 | SOLUTION SET/EXTENSION SET | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 11, 2014 | K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION | DPS | Substantially Equivalent | Welch Allyn | accessdata.fda.gov |
| July 10, 2014 | K140658 | THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 8, 2013 | K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 1, 2013 | K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | FMG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 8, 2013 | K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| August 2, 2012 | K122073 | ELI 280 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| March 23, 2012 | K120743 | SPECULUM, VAGINAL, NONMETAL | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| December 8, 2011 | K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | FPB | Substantially Equivalent | Baxter Healthcare Corp | 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 |
| June 14, 2011 | K111217 | ADDITIVE CAP | KPE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | 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 |
| March 16, 2011 | K103375 | PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Medtek Devices, Inc. | accessdata.fda.gov |
| October 21, 2010 | K101896 | MASIMO LNCS/M-LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| October 1, 2010 | K101880 | TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| August 23, 2010 | K101603 | BEAUTIFIL FLOW PLUS | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| July 21, 2010 | K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- | LZC | Substantially Equivalent | Kimberly-Clark | accessdata.fda.gov |
| July 9, 2010 | K101680 | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES | DXN | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| June 22, 2010 | K101385 | DUAL LUER LOCK CAP, MODEL 2C6250 | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 12, 2010 | K093556 | VCARE DX | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 9, 2009 | K082478 | WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 | BZG | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| February 23, 2009 | K083641 | BIVONA TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Smiths Medical Asd, 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 |
| October 5, 2007 | K071907 | VCARE RETRACTOR/ELEVATOR | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 11, 2005 | K050252 | AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| May 11, 2005 | K043203 | WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE | KNT | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| March 31, 2005 | K043418 | COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH | FED | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| February 11, 2004 | K033573 | LINVATEC 10K IRRIGATION SYSTEM | HRX | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| May 6, 2003 | K030580 | SURETEMP PLUS | FLL | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| September 17, 2002 | K022163 | WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 | DQA | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| August 13, 2002 | K021999 | GRIPPER PLUS NEEDLE | FPA | Substantially Equivalent | Deltec, Inc. | accessdata.fda.gov |
| August 12, 2002 | K022523 | RAPID-FILL TUBESET, MODEL 90005 | LHI | Substantially Equivalent | Baxa Corp. | accessdata.fda.gov |
| August 17, 2001 | K012455 | WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| January 25, 2001 | K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE | HLI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| December 5, 2000 | K002768 | ACAPELLA | BWF | Substantially Equivalent | Dhd Healthcare Corp. | accessdata.fda.gov |
| October 19, 2000 | K003225 | SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| November 17, 1999 | K993120 | MODIFIED BLOOD RECIPIENT SET | BRZ | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| August 11, 1999 | K983333 | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| August 24, 1998 | K982461 | GLASIONOMER CEMENT CX PLUS | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| August 17, 1998 | K981792 | SOLUTION ADMINISTRATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| July 14, 1997 | K963565 | MRI NEEDLES | FCG | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| March 31, 1997 | K964853 | INTRAVIA CONTAINER, EMPTY | KPE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| September 13, 1996 | K963088 | SHEATH, ELECTROSURGICAL PENCIL | GEI | Substantially Equivalent | Aspen Laboratories, Inc. | accessdata.fda.gov |
| June 21, 1996 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 14, 1996 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | LJH | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| December 6, 1994 | K931052 | METRICIDE 28 | MED | Substantially Equivalent | Metrex Research Corp. | accessdata.fda.gov |
| October 27, 1994 | K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| November 12, 1993 | K926477 | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO | GBW | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| November 3, 1993 | K930041 | VICROSAFE 6 AND VICROSAFE 12 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
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Updated March 25, 2024. 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.