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Data / Medical devices / Germany / Pajunk GMBH Medizintechnologie

Pajunk GMBH Medizintechnologie: FDA-registered device maker in GEISINGEN Baden-Wurttemberg, Germany, 44 510(k) clearances

Pajunk GMBH Medizintechnologie is registered with the FDA (registration 9611612) in GEISINGEN Baden-Wurttemberg, Germany. It lists 34 device types. The FDA files 44 510(k) clearances under its listings, the newest dated July 1, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Pajunk GMBH Medizintechnologie
FDA registration number
9611612
FEI number
3002807847
Address
Karl-Hall-Strasse 01, GEISINGEN Baden-Wurttemberg, Germany, 78187
Owner or operator
PAJUNK GmbH Medizintechnologie (8010639)
Roles
Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
First device listed
May 6, 1986
Registered through
2026
Brand names listed
BigFlow, CauDal, CauDal NRFit, CauDal Sono, Chiba, ChibaSono, Clamp w / DeBakey teeth, ClampingAdapter and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Pump, InfusionMRZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Anesthesia Conduction KitCAZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Biopsy NeedleFCG2Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, OphthalmicHMX1Manufactureraccessdata.fda.gov
Catheter, Conduction, AnestheticBSO2Contract manufacturer, Manufactureraccessdata.fda.gov
Custom Anesthesia TrayOGD2Repackager or relabeleraccessdata.fda.gov
Device, BiofeedbackHCC2Complaint file establishment, Manufactureraccessdata.fda.gov
Device, Percutaneous, BiopsyMJG1Contract manufacturer, Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufacturer, Manufactureraccessdata.fda.gov
Epidural Anesthesia KitOGE2Repackager or relabeleraccessdata.fda.gov
Filter, Conduction, AnestheticBSN2Manufactureraccessdata.fda.gov
Generator, Lesion, RadiofrequencyGXD2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Contract manufactureraccessdata.fda.gov
Instrument, BiopsyKNW2Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufactureraccessdata.fda.gov
Introducer, CatheterDYB2Contract manufacturer, Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Manufactureraccessdata.fda.gov
Manometer, Spinal-FluidFMJ2Manufactureraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Probe, Radiofrequency LesionGXI2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Spinal Anesthesia KitOFU2Repackager or relabeleraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Complaint file establishment, Manufactureraccessdata.fda.gov
Stimulator, Nerve, Battery-PoweredBXN2Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Complaint file establishment, Manufactureraccessdata.fda.gov
Stimulator, Neuromuscular, External FunctionalGZI2Complaint file establishment, Manufactureraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Manufactureraccessdata.fda.gov
System, Applicator, Radionuclide, ManualIWJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Manufactureraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Contract manufactureraccessdata.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
July 1, 2025K243690SonoMSKBSPSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
June 27, 2025K243682SonoPlex STIM; SonoPlex IIBSPSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
June 25, 2025K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSPSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
March 24, 2025K243525SonoTAP and SonoTAP IIBSPSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
November 22, 2024K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSPSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
September 11, 2024K241954SonoBlock; SonoBlock IIBSPSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
November 24, 2023K230701Stim2GoIPFSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
March 15, 2023K220122APEX 6GXDSubstantially EquivalentRf Innovations, Inc.accessdata.fda.gov
February 22, 2023K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0HAWSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
December 29, 2020K202699E-Cath STIM acc. TsuiCAZSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
June 17, 2019K190663Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6BSNSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
May 16, 2019K190345VPCCAZSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
May 3, 2018K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSOSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
July 25, 2017K170305Spinal Manometer NRFit; Spinal Manometer LUERFMJSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
July 12, 2017K170435NerveGuard NRFit, NerveGuard LUERBSPSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
January 6, 2017K162086MultiStim ECOBXNSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
October 28, 2016K160297Tuohy NRFitBSPSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
October 21, 2016K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesBSPSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
July 13, 2016K152952E-CathBSOSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
March 1, 2012K113188SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONGCAZSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
February 29, 2012K113207SONO TAP, TUOHY SONOBSPSubstantially EquivalentPajunk GmbHaccessdata.fda.gov
February 6, 2012K113196VASCULAR SONODYBSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
November 21, 2011K113209CHIBA SONOKNWSubstantially EquivalentPajunk GmbHaccessdata.fda.gov
April 16, 2009K090631PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMSGCJSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
June 20, 2008K080675PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KITBSOSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
May 9, 2008K080674PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEMMJGSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
June 7, 2007K062902PAJUNKS EPILONG SET PEDIATRICCAZSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
April 30, 2007K063233DELTACUT (APPARATUS AND CANNULA)KNWSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
February 14, 2007K063697SPECIAL SPROTTE, CHIBA, DR STEINHOFF KITKNWSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
October 13, 2006K062097VERESS CANNULA AND MODULAR VERESS CANNULAHETSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
October 5, 2006K062047ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODESGEISubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
September 22, 2006K062072PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODESGEISubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
August 31, 2006K060397RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEEDGXISubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
July 25, 2006K060808BRAINPRO, BRAINPRO ACCESSHAWSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
June 13, 2006K060311EPILONG KIT FOR ANESTHESIOLOGYCAZSubstantially EquivalentPAJUNK GmbH Medizintechnologieaccessdata.fda.gov
June 2, 2006K060563EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IVCAZSubstantially EquivalentPajunk GmbHaccessdata.fda.gov
January 12, 2006K053283UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SETCAZSubstantially EquivalentPajunk GmbHaccessdata.fda.gov
December 13, 2005K053282ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIPGEISubstantially EquivalentPajunk GmbHaccessdata.fda.gov
September 7, 2004K040965PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLESBSPSubstantially EquivalentPajunk GmbHaccessdata.fda.gov
March 5, 2004K033249PAJUNK MODULAR HANDLE INSTRUMENTSGCJSubstantially EquivalentPajunk GmbHaccessdata.fda.gov
November 14, 2001K012771TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XXGCJSubstantially EquivalentPajunk GmbHaccessdata.fda.gov
September 6, 2001K011387NEUROTHERM, MODEL JK4GXISubstantially EquivalentEurolink, LLCaccessdata.fda.gov
July 10, 2001K011997MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XXGCJSubstantially EquivalentPajunk GmbHaccessdata.fda.gov
July 24, 1992K911221ATRAUMATIC SPECIAL SPROTTE NEEDLEBSPSubstantially EquivalentPajunk GmbHaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 30, 201983714Class IIOngoingSPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25Problem with packaging sealing process which affects sterility.accessdata.fda.gov

Compare with other makers

Updated July 1, 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.