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Data / Medical devices / Germany / Medi.plan GMBH & Co. KG

Medi.plan GMBH & Co. KG: FDA-registered device maker in Dortmund North Rhine-Westphalia, Germany, 34 510(k) clearances

Medi.plan GMBH & Co. KG is registered with the FDA (registration 3033536319) in Dortmund North Rhine-Westphalia, Germany. It lists 46 device types. The FDA files 34 510(k) clearances under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Medi.plan GMBH & Co. KG
FDA registration number
3033536319
Address
Hofkerstrabe 22, Dortmund North Rhine-Westphalia, Germany, 44149
Owner or operator
MEDI.PLAN GmbH & Co. KG (10091549)
Roles
Exporter to the US
First device listed
October 14, 2024
Registered through
2026
Brand names listed
703418 Disposable Flow Transducers QTY 25, ACTICOAT FLEX 3 10X10CM PACK 12, ACTIVELIFE ONE-PIECE DRAINABLE POUCH PACK 10, ADULT ANEROID ONE PIECE WITH CUFF PACK 1, ALLEVYN ADH 12.5X12.5CM PACK 10, ALLEVYN GENTLE BORDER 10X10CM PACK 10, ALLEVYN GENTLE BORDER 12.5X12.5CM PACK 10, ALLEVYN GENTLE BORDER 17.5X17.5CM PACK 10 and more

Devices it lists

DeviceProduct codeClassRoleSource
ArthroscopeHRX2Exporter to the USaccessdata.fda.gov
Bag, Urinary, IleostomyEXH1Exporter to the USaccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Exporter to the USaccessdata.fda.gov
Blood Pressure CuffDXQ2Exporter to the USaccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Exporter to the USaccessdata.fda.gov
Container, I.V.KPE2Exporter to the USaccessdata.fda.gov
Container, Specimen, SterileFMH1Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Exporter to the USaccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Exporter to the USaccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Exporter to the USaccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Exporter to the USaccessdata.fda.gov
Elastomer, Silicone, For Scar ManagementMDA1Exporter to the USaccessdata.fda.gov
ElectrocardiographDPS2Exporter to the USaccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the USaccessdata.fda.gov
ExophthalmometerHLS1Exporter to the USaccessdata.fda.gov
Filter, Infusion LineFPB2Exporter to the USaccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Hood, SurgicalFXY2Exporter to the USaccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Exporter to the USaccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUExporter to the USaccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Ophthalmoscope, Ac-PoweredHLI2Exporter to the USaccessdata.fda.gov
Ophthalmoscope, Battery-PoweredHLJ2Exporter to the USaccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Exporter to the USaccessdata.fda.gov
OtoscopeERA1Exporter to the USaccessdata.fda.gov
Protector, Skin PressureFMP1Exporter to the USaccessdata.fda.gov
Retinoscope, Battery-PoweredHKM1Exporter to the USaccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the USaccessdata.fda.gov
Set, Blood TransfusionBRZ2Exporter to the USaccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Exporter to the USaccessdata.fda.gov
Spirometer, DiagnosticBZG2Exporter to the USaccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the USaccessdata.fda.gov
Stopcock, I.V. SetFMG2Exporter to the USaccessdata.fda.gov
Syringe, AntistickMEG2Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
System, Irrigation, UrologicalLJH2Exporter to the USaccessdata.fda.gov
System/Device, Pharmacy CompoundingNEP2Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Exporter to the USaccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 28, 2025K242339Intravascular Extension Sets and AccessoriesFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
July 25, 2024K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting AccessoriesOLOSubstantially EquivalentStryker Leibinger GmbH & Co KGaccessdata.fda.gov
March 10, 2023K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceJKASubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
February 3, 2022K213824Sonopet iQ Ultrasonic Aspirator SystemLFLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
March 21, 2020K200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverFXYSubstantially EquivalentStryker Corporationaccessdata.fda.gov
September 10, 2019K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZGSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
March 20, 2019K183399BD Nexiva Closed IV Catheter SystemFOZSubstantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.accessdata.fda.gov
September 22, 2017K172544IV Fat Emulsion Administration SetsFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
December 19, 2016K162081BD 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 SyringeFMFSubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
December 19, 2016K160007Paclitaxel SetsFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
December 28, 2015K153158Solution Administration Sets with 0.2 Micron FilterFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
June 24, 2015K120577MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DXBZGSubstantially EquivalentMedikro OYaccessdata.fda.gov
August 18, 2014K142011SOLUTION SET/EXTENSION SETFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
October 8, 2013K132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
March 1, 2013K130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOFMGSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
January 8, 2013K123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SETFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
October 18, 2011K112893CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
March 25, 2011K103551INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,FPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
June 22, 2010K101385DUAL LUER LOCK CAP, MODEL 2C6250FPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
July 22, 2009K083113ACTICOAT FLEX 7 DRESSINGFROSubstantially EquivalentSmith & Nephew, Inc.accessdata.fda.gov
December 18, 2007K070060WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)DXQSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
November 30, 2007K073017STRYKER STRI-SHIELD FLYTE TOGASFYASubstantially EquivalentStryker Instruments, Instruments Div.accessdata.fda.gov
March 23, 2007K063005STRYKER T6 HOODS AND TOGASFYASubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
February 25, 2004K033232COLORADO MICRODISSECTION NEEDLEGEISubstantially EquivalentStryker Corp.accessdata.fda.gov
May 6, 2003K030580SURETEMP PLUSFLLSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
August 17, 2001K012455WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEMDXQSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
January 25, 2001K003376WELCH ALLYN 11800 OPTHALMOSCOPEHLISubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
November 17, 1999K993120MODIFIED BLOOD RECIPIENT SETBRZSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
October 1, 1999K992734BECTON DICKINSON SYRINGEMEGSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
March 31, 1997K964853INTRAVIA CONTAINER, EMPTYKPESubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
June 21, 1996K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
May 14, 1996K960787TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSLJHSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
October 7, 1995K951254SAFETYGLIDE NEEDLEFMISubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
October 9, 1987K872743BAXA TUBING SETS (FOR PHARMACY PUMP)FMFSubstantially EquivalentBaxa Corp., Sub. of Cook Group, Inc.accessdata.fda.gov

Compare with other makers

Updated February 28, 2025. 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.