FDA Registration
Active
🇩🇪 Germany
Instrumed GmbH dba Avalign German Specialty Instruments
Reg #: 8010372
·
FEI: 3007290840
·
Expires 2026
Products
97
Proprietary Names
1
Establishment Types
3
Classifications
97
Registration Details
- Registration Name
- Instrumed GmbH dba Avalign German Specialty Instruments
- Registration Number
- 8010372
- FEI Number
- 3007290840
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3 Unter Buchsteig
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K980002
Owner / Operator
- Firm Name
- Avalign Technologies
- Operator Number
- 10051835
- Address
- 110275 W. Higgins Rd, Suite 920
- City
- Rosemont
- State
- IL
- Postal Code
- 60018
- Country
- US
- Correspondent
- Heidi Funston
US Agent
- Business Name
- Avalign Technologies
- Contact Name
- Heidi Funston
- Address
- 10275 W Higgins Rd Suite 920
- City
- Rosemont
- State
- IL
- ZIP
- 60018
- Country
- US
- [email protected]
- Phone
- 260 4841500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2016-11-17 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2016-11-17 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2016-11-17 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2016-11-16 |
| Probe | HXB | Class 1 | Orthopedic | No | 2016-11-17 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Rod, Measuring Ear | JYZ | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2016-11-21 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2016-11-16 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2016-11-16 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2016-11-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Bar, Preformed | EHO | Class 1 | Dental | No | 2016-11-17 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2016-11-16 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Crimper, Wire, Ent, Non-Sterile | NNN | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2016-11-16 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2016-11-17 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2016-11-16 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Needle, Gastro-Urology | FHR | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2016-11-17 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2016-11-17 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Needle, Neurosurgical Suture | HAS | Class 1 | Neurology | No | 2016-11-17 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2018-03-28 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2016-09-21 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2016-11-17 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2016-11-16 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2016-11-16 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Dilator, Vessel, Surgical | DWP | Class 2 | Cardiovascular | No | 2016-09-21 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-05-09 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2016-11-17 |
| Cannula, Ear | JYC | Class 1 | General, Plastic Surgery | No | 2017-01-19 |
| Aspiration Tray | OJT | Class 1 | General, Plastic Surgery | No | 2020-05-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-11-17 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2016-09-21 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2016-11-16 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2017-01-19 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-09-21 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-09-21 |
| Mobilizer, Ent | KAJ | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2016-11-16 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2016-11-17 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2016-11-17 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 2016-11-21 |
| Punch, Antrum | KAW | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2016-05-09 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2016-11-15 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2016-11-16 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2016-11-16 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2016-11-21 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Fork | HXE | Class 1 | Orthopedic | No | 2016-11-21 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2018-04-04 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2016-11-16 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
Proprietary Names
Joint Aspiration Tray
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility