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Data / Medical devices / Germany / Simex Medizintechnik GMBH

Simex Medizintechnik GMBH: FDA-registered device maker in Deisslingen Baden-Wurttemberg, Germany, 4 510(k) clearances

Simex Medizintechnik GMBH is registered with the FDA (registration 3005813597) in Deisslingen Baden-Wurttemberg, Germany. It lists 46 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 5, 2016. Registered through 2026. FDA data exported November 3, 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 Simex Medizintechnik GMBH
FDA registration number
3005813597
Address
Brueckstr. 30/1, Deisslingen Baden-Wurttemberg, Germany, 78652
Owner or operator
SIMEX MEDIZINTECHNIK GMBH (9086230)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
September 17, 2012
Registered through
2026
Brand names listed
Bit, Drill, Chisel (Osteotome), Chisel, Surgical, Manual, Clamp, Curette, Periodontic, Cutter, Surgical, Cutter, Wire, Depressor, Tongue, Non-Surgical and more

Devices it lists

DeviceProduct codeClassRoleSource
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Chisel (Osteotome)KDG1Repackager or relabeleraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Repackager or relabeleraccessdata.fda.gov
ClampHXD1Repackager or relabeleraccessdata.fda.gov
Curette, PeriodonticEMS1Repackager or relabeleraccessdata.fda.gov
Cutter, SurgicalFZT1Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Repackager or relabeleraccessdata.fda.gov
Dilator, CatheterGCC1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Repackager or relabeleraccessdata.fda.gov
Dilator, TrachealKCG1Repackager or relabeleraccessdata.fda.gov
ElevatorHTE1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Repackager or relabeleraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Repackager or relabeleraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Repackager or relabeleraccessdata.fda.gov
Hammer, SurgicalFZY1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
HemostatHRQ1Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Repackager or relabeleraccessdata.fda.gov
Hook, TrachealKCH1Repackager or relabeleraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
MalletHXL1Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Repackager or relabeleraccessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction PumpOMP2Manufacturer, Specification developeraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Manufactureraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
SawHSO1Repackager or relabeleraccessdata.fda.gov
Scaler, PeriodonticEMN1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Repackager or relabeleraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Repackager or relabeleraccessdata.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
January 5, 2016K150459FloSure Ventilation PatchOMPSubstantially EquivalentSimex Medizintechnik GmbHaccessdata.fda.gov
September 22, 2014K141255SIMEX SUBGLOTTIC ASPIRATION SYSTEMBTASubstantially EquivalentSimex Medizintechnik GmbHaccessdata.fda.gov
August 30, 2012K113291SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300OMPSubstantially EquivalentSimex Medizintechnik GmbHaccessdata.fda.gov
January 5, 2012K112458PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEMOMPSubstantially EquivalentMedica-Rents Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 5, 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.