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Data / Medical devices / Germany / Ackermann Instrumente GMBH

Ackermann Instrumente GMBH: FDA-registered device maker in RIETHEIM, WEILHEIM Baden-Wurttemberg, Germany, 4 510(k) clearances

Ackermann Instrumente GMBH is registered with the FDA (registration 8010273) in RIETHEIM, WEILHEIM Baden-Wurttemberg, Germany. It lists 58 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 17, 2016. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
8010273
FEI number
4486
Address
Eisenbahnstr. 65-67, RIETHEIM, WEILHEIM Baden-Wurttemberg, Germany, D-78604
Owner or operator
ACKERMANN INSTRUMENTE GMBH (8010273)
Roles
Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed
January 30, 1996
Registered through
2027
Brand names listed
ACKERMANN LED LIGHT SOURCE, ACKERMANN URETHROTOME, Ackermann Diflex System, Ackermann Fusion Insufflator, Ackermann Intervertebral Body Fusion Device, Ackermann Suturing Needle Instrument, Applier , Surgical Clips, Applier Clip and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufactureraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Manufactureraccessdata.fda.gov
Applier, Hemostatic ClipHBT1Manufactureraccessdata.fda.gov
Applier, Surgical, ClipGDO1Contract manufacturer, Manufactureraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Contract manufactureraccessdata.fda.gov
CaliperKTZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Manufactureraccessdata.fda.gov
Cannula, InjectionFGY1Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufactureraccessdata.fda.gov
Cannulae, BronchialKCE1Manufactureraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Manufactureraccessdata.fda.gov
Clip, HemostaticMCH2Manufactureraccessdata.fda.gov
Clip, ImplantableFZP2Manufactureraccessdata.fda.gov
Curette, NasalKAP1Manufactureraccessdata.fda.gov
Curette, Surgical, General UseFZS1Contract manufacturer, Manufactureraccessdata.fda.gov
Dislodger, Stone, FlexibleFGO2Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufactureraccessdata.fda.gov
Dissector, TonsilKBM1Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Contract manufacturer, Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Manufactureraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Foreign private label distributor, Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Manufactureraccessdata.fda.gov
Knife, EntKTG1Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Contract manufacturer, Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Led Light SourceNTN2Manufactureraccessdata.fda.gov
Medical Device Data SystemOUG1Manufactureraccessdata.fda.gov
Mirror, General & Plastic SurgeryFTX1Contract manufacturer, Manufactureraccessdata.fda.gov
OtoscopeERA1Manufactureraccessdata.fda.gov
ProbeHXB1Contract manufacturer, Manufactureraccessdata.fda.gov
Punch, AntrumKAW1Manufactureraccessdata.fda.gov
Punch, EntKTF1Manufactureraccessdata.fda.gov
Punch, NasalKAY1Manufactureraccessdata.fda.gov
Punch, SurgicalLRY1Manufactureraccessdata.fda.gov
RaspHTR1Contract manufacturer, Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Retractor, Self-RetainingFFO1Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Manufactureraccessdata.fda.gov
Speculum, EntEPY1Contract manufacturer, Manufactureraccessdata.fda.gov
Speculum, Non-IlluminatedFXE1Manufactureraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Contract manufacturer, Manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Contract manufacturer, Manufactureraccessdata.fda.gov
Table And Attachments, Operating-RoomBWN1Contract manufacturer, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Manufactureraccessdata.fda.gov
UrethrotomeEZO2Manufactureraccessdata.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
June 17, 2016K153367S698 Symbioz flowHIFSubstantially EquivalentSopro - Acteon Groupaccessdata.fda.gov
September 16, 2015K143450Ackermann Intervertebral Body Fusion DeviceODPSubstantially EquivalentAckermann Instrumente GmbHaccessdata.fda.gov
November 8, 2011K111930ACKERMANN EUROPCLIPFZPSubstantially EquivalentAckermann Instrumente GmbHaccessdata.fda.gov
April 21, 1998K974382ACKERMANN SURGICAL INSTRUMENTSGCJSubstantially EquivalentAckermann Instrumente GmbHaccessdata.fda.gov

Compare with other makers

Updated June 17, 2016. 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.