Data / Medical devices / Germany / Ustomed Instrumente GMBH & Co. KG
Ustomed Instrumente GMBH & Co. KG: FDA-registered device maker in Tuttlingen Baden-Wurttemberg, Germany, 1 510(k) clearance
Ustomed Instrumente GMBH & Co. KG is registered with the FDA (registration 3002808270) in Tuttlingen Baden-Wurttemberg, Germany. It lists 90 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 5, 2013. 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.
- FDA registration number
- 3002808270
- Address
- Bischof Sproll Str. 2, Tuttlingen Baden-Wurttemberg, Germany, 78532
- Owner or operator
- USTOMED INSTRUMENTE GMBH & CO. KG (10048936)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- April 20, 2015
- Registered through
- 2026
- Brand names listed
- Aspirateur de Yankauer, Splinter forceps
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Retractor, Dental | EIF | 1 | Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Manufacturer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Bone Mill | LYS | 1 | Manufacturer | accessdata.fda.gov |
| Bone Particle Collector | MXP | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Injection | FGY | 1 | Manufacturer | accessdata.fda.gov |
| Carrier, Amalgam, Operative | EKI | 1 | Manufacturer | accessdata.fda.gov |
| Carver, Dental Amalgam, Operative | EKH | 1 | Manufacturer | accessdata.fda.gov |
| Carver, Wax, Dental | EIK | 1 | Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Infusion | JCY | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Nasal, Oxygen | BZB | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Manufacturer | accessdata.fda.gov |
| Clamp | HXD | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Rubber Dam | EEF | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Manufacturer | accessdata.fda.gov |
| Curette | HTF | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Endodontic | EKT | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Nasal | KAP | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Manufacturer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Esophageal, Ent | KCF | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Manufacturer | accessdata.fda.gov |
| Excavator, Dental, Operative | EKC | 1 | Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Articulation Paper | EFK | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Manufacturer | accessdata.fda.gov |
| Frame, Rubber Dam | EJE | 1 | Manufacturer | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Manufacturer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Manufacturer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Contouring, Matrix, Operative | EKF | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Periodontic | EMO | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Manufacturer | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Manufacturer | accessdata.fda.gov |
| Punch, Adenoid | KBS | 1 | Manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Manufacturer | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Manufacturer | accessdata.fda.gov |
| Reamer, Pulp Canal, Endodontic | EKP | 1 | Manufacturer | accessdata.fda.gov |
| Remover, Crown | EIS | 1 | Manufacturer | accessdata.fda.gov |
| Retainer, Matrix | JEP | 1 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Manufacturer | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Wire Cutting, Ent, Non-Sterile | NNU | 1 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Screwdriver, Surgical | LRZ | 1 | Manufacturer | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Manufacturer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Manufacturer | accessdata.fda.gov |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | 1 | Manufacturer | accessdata.fda.gov |
| Staple Driver | HXJ | 1 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Dental) | EIB | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
Compare with other makers
Updated July 5, 2013. 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.