Simex Medizintechnik GmbH
Deisslingen Baden-Wurttemberg, DE
SIMEX MEDIZINTECHNIK GMBH appears in FDA device records in Deisslingen Baden-Wurttemberg, DE. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Simex Medizintechnik GmbH between 2012 and 2016. The busiest year on record is 2012, with 1. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150459 | FloSure Ventilation Patch | OMP | Substantially Equivalent | |
| K141255 | SIMEX SUBGLOTTIC ASPIRATION SYSTEM | BTA | Substantially Equivalent | |
| K113291 | SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 | OMP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005813597 | 3005813597 | SIMEX MEDIZINTECHNIK GMBH | Brueckstr. 30/1, Deisslingen Baden-Wurttemberg 78652 DE | 2026 | and 36 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HTWBit, Drill
- KDGChisel (Osteotome)
- FZOChisel, Surgical, Manual
- HXDClamp
- EMSCurette, Periodontic
- FZTCutter, Surgical
- HXZCutter, Wire
- FMADepressor, Tongue, Non-Surgical
- GCCDilator, Catheter
- HDQDilator, Cervical, Fixed Size
- KCGDilator, Tracheal
- HTEElevator
- EMJElevator, Surgical, Dental
- GENForceps, General & Plastic Surgery
- EMHForceps, Rongeur, Surgical
- KBNGag, Mouth
- GDHGouge, Surgical, General & Plastic Surgery
- GDFGuide, Needle, Surgical
- FZYHammer, Surgical
- GDZHandle, Scalpel
- HRQHemostat
- GDGHook, Surgical, General & Plastic Surgery
- KCHHook, Tracheal
- LGGInstrument, Cast Application/Removal, Manual
- KOHInstrument, Manual, General Obstetric-Gynecologic
- CCWLaryngoscope, Rigid
- HXLMallet
- EAXMirror, Mouth
- GDLNeedle, Suturing, Reusable
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- HNLProbe, Lachrymal
- BTAPump, Portable, Aspiration (Manual Or Powered)
- LRYPunch, Surgical
- GADRetractor
- EIGRetractor, All Types
- HSOSaw
- EMNScaler, Periodontic
- LRWScissors, General, Surgical
- HNFScissors, Ophthalmic
- HHMSound, Uterine
- GAFSpatula, Surgical, General & Plastic Surgery
- HDFSpeculum, Vaginal, Metal
- EICSyringe, Periodontic, Endodontic, Irrigating
- EHYTray, Impression, Preformed
- FSMTray, Surgical, Instrument
- KCBTube, Tonsil Suction
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Simex Medizintechnik GmbH edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain