FDA Registration
Active
🇩🇪 Germany
RUDOLF STORZ GMBH
Reg #: 9611274
·
FEI: 3002808043
·
Expires 2026
Products
99
Proprietary Names
3
Establishment Types
2
Classifications
99
Registration Details
- Registration Name
- RUDOLF STORZ GMBH
- Registration Number
- 9611274
- FEI Number
- 3002808043
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FRIEDRICH-WOEHLER-STR. 13
- City
- EMMINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K033660
Owner / Operator
- Firm Name
- RUDOLF STORZ GMBH
- Operator Number
- 8010286
- Address
- FRIEDRICH-WOEHLER-STR.13, --
- City
- EMMINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78576
- Country
- DE
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Contractor, Surgical | FZR | Class 1 | General, Plastic Surgery | No | 2000-04-11 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2013-01-15 |
| Tonsillectome | KCA | Class 1 | Ear, Nose, Throat | No | 2020-11-23 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2011-01-31 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2007-11-22 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2013-02-14 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2012-09-18 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2013-02-03 |
| Tong, Skull For Traction | HAX | Class 2 | Neurology | No | 2008-03-06 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2013-03-07 |
| Tourniquet, Gastro-Urology | EYR | Class 1 | General, Plastic Surgery | No | 2020-11-23 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1986-06-02 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2013-03-07 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2006-04-18 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2018-05-08 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2012-12-29 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2011-06-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2001-04-13 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 1978-06-02 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2013-02-25 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2020-11-23 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-02-03 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2021-06-29 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 1998-01-05 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2015-11-12 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 1998-01-05 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 1986-06-02 |
| Curette, Operative | EKE | Class 1 | Dental | No | 1998-01-05 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1986-06-05 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2000-04-11 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 1986-06-02 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-02-07 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2025-11-27 |
| Template | HWT | Class 1 | Orthopedic | No | 2022-07-13 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2020-11-23 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2000-04-11 |
| Fork | HXE | Class 1 | Orthopedic | No | 2016-11-22 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-11-15 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2010-03-05 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2007-01-24 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1986-06-02 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2010-09-13 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2013-02-03 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-12-18 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-12-18 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-12-18 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2013-02-03 |
| Anvil, Skull Plate | GXM | Class 1 | Neurology | No | 1998-01-05 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-06-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1986-06-02 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-10-26 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 1986-06-02 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2000-04-11 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2007-01-24 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2013-02-03 |
| Clip, Scalp | HBO | Class 2 | Neurology | No | 2007-11-22 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2013-02-06 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2003-03-17 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2010-03-05 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-02-25 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 1998-01-05 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2013-02-27 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1978-06-02 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2007-06-07 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1998-01-05 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2010-04-19 |
| Handpiece (Brace), Drill | HBD | Class 1 | Neurology | No | 2000-10-31 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-02-07 |
| Probe, Rectal, Non-Powered | EXX | Class 1 | Gastroenterology, Urology | No | 2013-02-07 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 1986-06-05 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2011-02-17 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2013-03-07 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1986-06-02 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-03-07 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-03-07 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2016-02-04 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-11-22 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 1986-06-02 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 1986-06-02 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2024-06-28 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2006-03-06 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1998-01-05 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 1986-06-02 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2018-11-09 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2016-11-22 |
| Headrest, Neurosurgical | HBM | Class 1 | Neurology | No | 2019-04-12 |
| Trephine | HWK | Class 1 | Orthopedic | No | 1998-01-05 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1986-06-02 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-02-25 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2005-09-27 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 2013-02-03 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 1986-06-02 |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | Class 1 | Obstetrics/Gynecology | No | 2000-10-31 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2013-02-03 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 2020-11-23 |
| Graft, Vascular, Stainless Steel Tunneler | MZY | Class 2 | Cardiovascular | No | 2012-12-29 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1986-06-02 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-02-25 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2010-09-24 |
Proprietary Names
T2 ICF System
Retractor, Surgical, General & Plastic Surgery
06-60-1010
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device