Data / Medical devices / Germany / Rudolf Medical GMBH + Co. KG
Rudolf Medical GMBH + Co. KG: FDA-registered device maker in FRIDINGEN Baden-Wurttemberg, Germany, 1 510(k) clearance
Rudolf Medical GMBH + Co. KG is registered with the FDA (registration 8010298) in FRIDINGEN Baden-Wurttemberg, Germany. It lists 94 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 19, 2008. Registered through 2027. 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
- 8010298
- FEI number
- 3003448211
- Address
- Zollerstrasse 1, FRIDINGEN Baden-Wurttemberg, Germany, 78567
- Owner or operator
- RUDOLF MEDICAL GMBH + CO. KG (8010298)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- December 30, 1977
- Registered through
- 2027
- Brand names listed
- CLIP, CUSHING ELEVATOR WIDE, SHARP END ROUND EDGE ON "S" CURVED SHANK, OVERALL LENGTH 7-1/2"(19.1CM), DISSECTING SCISSORS, FENESTROMETER, Rosen myringotomy, JOSEF SCISSORS, SCISSORS MAYO-STILLE, CURVED TC, Scissors Esmarch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Arthroscopic | NBH | 1 | Contract manufacturer | accessdata.fda.gov |
| Applier, Aneurysm Clip | HCI | 2 | Contract manufacturer | accessdata.fda.gov |
| Applier, Cerclage | HXN | 1 | Contract manufacturer | accessdata.fda.gov |
| Applier, Surgical, Clip | GDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Contract manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Contract manufacturer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Contract manufacturer | accessdata.fda.gov |
| Bougie, Urological | FAX | 1 | Contract manufacturer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Contract manufacturer | accessdata.fda.gov |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | 1 | Contract manufacturer | accessdata.fda.gov |
| Cannula, Sinus | KAM | 1 | Contract manufacturer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Cholangiography | GBZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Contract manufacturer | accessdata.fda.gov |
| Clamp | HXD | 1 | Contract manufacturer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Clip, Aneurysm | HCH | 2 | Contract manufacturer | accessdata.fda.gov |
| Clip, Removable (Skin) | FZQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Curette | HTF | 1 | Contract manufacturer | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Contract manufacturer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Contract manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Dilator, Tracheal | KCG | 1 | Contract manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Contract manufacturer | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Contract manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Contract manufacturer | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Contract manufacturer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Contract manufacturer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Contract manufacturer | accessdata.fda.gov |
| Forceps, Surgical, Gynecological | HCZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Contract manufacturer | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Contract manufacturer | accessdata.fda.gov |
| Gauge, Measuring | JYJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Contract manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Contract manufacturer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Contract manufacturer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Contract manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Contract manufacturer | accessdata.fda.gov |
| Knife, Amputation | GDN | 1 | Contract manufacturer | accessdata.fda.gov |
| Knife, Ear | JYO | 1 | Contract manufacturer | accessdata.fda.gov |
| Knife, Ent | KTG | 1 | Contract manufacturer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Contract manufacturer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Contract manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Contract manufacturer | accessdata.fda.gov |
| Light Source, Endoscope, Xenon Arc | GCT | 2 | Contract manufacturer | accessdata.fda.gov |
| Light, Surgical Headlight | EBA | 1 | Contract manufacturer | accessdata.fda.gov |
| Loop, Wire | JYQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Marker, Sclera | HMQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Contract manufacturer | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Contract manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Contract manufacturer | accessdata.fda.gov |
| Probe | HXB | 1 | Contract manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Contract manufacturer | accessdata.fda.gov |
| Rasp | HTR | 1 | Contract manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Contract manufacturer | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Contract manufacturer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Contract manufacturer | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Contract manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Contract manufacturer | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Contract manufacturer | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Contract manufacturer | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Contract manufacturer | accessdata.fda.gov |
| Scoop | FHL | 1 | Contract manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Contract manufacturer | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Contract manufacturer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Contract manufacturer | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Contract manufacturer | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Contract manufacturer | accessdata.fda.gov |
| Stripper, Vein, Reusable | GAI | 1 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Test, Spectacle Dissociation, Battery-Powered (Lancaster) | HLO | 1 | Contract manufacturer | accessdata.fda.gov |
| Tonsillectome | KCA | 1 | Contract manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Contract manufacturer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Contract manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Contract 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 |
|---|
| September 19, 2008 | K073498 | LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM | GEI | Substantially Equivalent | Rudolf Medical GmbH + Co. KG | accessdata.fda.gov |
Compare with other makers
Updated September 19, 2008. 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.