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Data / Medical devices / Germany / Kaul Medizintechnik GMBH

Kaul Medizintechnik GMBH: FDA-registered device maker in Dierdorf Rhineland-Palatinate, Germany, 13 510(k) clearances

Kaul Medizintechnik GMBH is registered with the FDA (registration 3029933740) in Dierdorf Rhineland-Palatinate, Germany. It lists 13 device types. The FDA files 13 510(k) clearances under its listings, the newest dated November 30, 2023. 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 Kaul Medizintechnik GMBH
FDA registration number
3029933740
Address
Konigsberger Street 40, Dierdorf Rhineland-Palatinate, Germany, 56269
Owner or operator
KAUL MEDIZINTECHNIK GMBH (10089013)
Roles
Complaint file establishment, Foreign private label distributor, Manufacturer, Specification developer
First device listed
October 28, 2023
Registered through
2026
Brand names listed
0.8 mm Phalange Implant and Instrument Case, 1.3 mm Metacarpal Implant and Instrument Case, 1.5mm Screw Caddy for CMF System, 1.8 mm Variable Angle Locking Drill Guide, Conical, 10mm Drill Chuck Key- 1:1 Multipurpose Attachment, 10mm Drill for KS-13 Anterior Cervical Plate Instrument Set, 12/8mm Protection Sleeve for KN-8 Talus Nail, 125 Degree Proximal Targeting Device, Aluminium, for KN-3 Nail and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Complaint file establishment, Foreign private label distributor, Specification developeraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Single ComponentKTW2Complaint file establishment, Foreign private label distributor, Specification developeraccessdata.fda.gov
CorkscrewHWI1Manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Complaint file establishment, Foreign private label distributor, Specification developeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Nail, Fixation, BoneJDS2Complaint file establishment, Foreign private label distributor, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Complaint file establishment, Foreign private label distributor, Specification developeraccessdata.fda.gov
ReamerHTO1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Complaint file establishment, Foreign private label distributor, Specification developeraccessdata.fda.gov
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc UsePYO1Manufacturer, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Foreign private label distributor, Specification developeraccessdata.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
November 30, 2023K221787Auxein's DHS/DCS Plate SystemKTTSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
January 27, 2023K213059Tibia and Fibula SystemHRSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
December 16, 2022K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorMBISubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
November 18, 2022K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateMBISubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
November 4, 2022K213108Humerus & Ulna SystemHRSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
October 3, 2022K213014Varixis Elbow SystemHRSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
August 22, 2022K213109Auxilock Draw Tight Suture-Based AnchorMBISubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
July 29, 2022K213104Auxilock Titanium Screw-In Suture AnchorMBISubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
March 14, 2022K2113242.4mm Distal Radius SystemHRSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
August 20, 2021K203029Auxilock Titanium Interference ScrewHWCSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
April 6, 2021K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemNKBSubstantially EquivalentAuxein Medical Private Limited/71164accessdata.fda.gov
June 10, 2020K192003Auxein Nailing SystemJDSSubstantially EquivalentAuxein Medical Private Limitedaccessdata.fda.gov
June 30, 2015K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking ScrewsHRSSubstantially EquivalentAuxein Medicalaccessdata.fda.gov

Compare with other makers

Updated November 30, 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.