Geomed Medizin-Technik GmbH & Co. KG
TUTTLINGEN Baden-Wurttemberg, DE
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG appears in FDA device records in TUTTLINGEN Baden-Wurttemberg, DE. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Geomed Medizin-Technik GmbH & Co. KG carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Geomed Medizin-Technik GmbH & Co.510(k), recall
510(k) clearance history
FDA records hold 4 510(k) clearances for Geomed Medizin-Technik GmbH & Co. KG between 2005 and 2020. The busiest year on record is 2005, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2010 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201279 | ASSISTO Universal Applicator Clamping Device | JAQ | Substantially Equivalent | |
| K183438 | Geomed Vascular Dilators | DWP | Substantially Equivalent | |
| K102048 | ATRAUMATIC VASCULAR CLAMPS | DXC | Substantially Equivalent | |
| K052745 | ASSISTO ARM SYSTEMS | GWG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010168 | 1000453845 | GEOMED MEDIZIN-TECHNIK GMBH & CO. KG | LUDWIGSTALER STRASSE 27, TUTTLINGEN Baden-Wurttemberg D-78532 DE | 2026 | and 37 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HXDClamp
- GDJClamp, Surgical, General & Plastic Surgery
- DXCClamp, Vascular
- HXZCutter, Wire
- DWPDilator, Vessel, Surgical
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- GWGEndoscope, Neurological
- HFBForceps, Biopsy, Gynecological
- KAEForceps, Ent
- GENForceps, General & Plastic Surgery
- HDAForceps, Obstetrical
- EMHForceps, Rongeur, Surgical
- EJGForceps, Rubber Dam Clamp
- HCZForceps, Surgical, Gynecological
- EMGForceps, Tooth Extractor, Surgical
- HYAForceps, Wire Holding
- FHQHolder, Needle, Gastroenterologic
- JYMInserter, Myringotomy Tube
- LGGInstrument, Cast Application/Removal, Manual
- HTZInstrument, Cutting, Orthopedic
- LRCInstrument, Ent Manual Surgical
- MDMInstrument, Manual, Surgical, General Use
- GZXInstrument, Microsurgical
- HAOInstrument, Surgical, Non-Powered
- DWSInstruments, Surgical, Cardiovascular
- GCJLaparoscope, General & Plastic Surgery
- JYRNipper, Malleus
- FWZOperating Room Accessories Table Tray
- LXHOrthopedic Manual Surgical Instrument
- JEXPlier, Orthodontic
- KBSPunch, Adenoid
- KBTPunch, Tonsil
- GACRasp, Surgical, General & Plastic Surgery
- KALRetractor, Ent
- HTXRongeur
- JZARongeur, Mastoid
- KBBRongeur, Nasal
- EIRScissors, Collar And Crown
- JZBScissors, Ear
- LRWScissors, General, Surgical
- KBDScissors, Nasal
- HNFScissors, Ophthalmic
- HRRScissors, Orthopedic, Surgical
- EGNScissors, Surgical Tissue, Dental
- NNUScissors, Wire Cutting, Ent, Non-Sterile
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- HXSTwister, Wire
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1061-2012 | ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular, articulated arms. Product Usage: ASSISTO Arm Systems with a holding power of up to 50N are designed as universal support systems for ventilator tubing and breathing tubes. When equipped with the appropriate accessories these arm systems may also be used to hold endoscopes. They are usually proved with non-insulated clamp sockets. All ASSISTO Arm Systems with a holding power of up to 100N are designed as universal support and holding systems for endoscope holders and detractors or other accessories. These systems are attached to the operating table with an electrically insulated clamp socket and are designed to hold the accessory in the desired position for a short period of time (which may exceed 60 minutes. | The product may fracture during surgical procedures. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain