FDA Registration
Active
🇩🇪 Germany
MEDICON, E.G.
Reg #: 8010099
·
FEI: 5870
·
Expires 2026
Products
184
Proprietary Names
5
Establishment Types
4
Classifications
184
Registration Details
- Registration Name
- MEDICON, E.G.
- Registration Number
- 8010099
- FEI Number
- 5870
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GAENSAECKER 15
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K242764
Owner / Operator
- Firm Name
- MEDICON, E.G.
- Operator Number
- 9018008
- Address
- GAENSAECKER 15, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- D-78532
- Country
- DE
- Correspondent
- Mario - Waizenegger
US Agent
- Business Name
- BUSINESS SUPPORT INTERNATIONAL
- Contact Name
- Angelika Scherp
- Address
- 1350 Avenue of the Americas, 2nd Floor
- City
- New York
- State
- NY
- ZIP
- 10019
- Country
- US
- [email protected]
- Phone
- 212 3318358 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 2002-03-07 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2002-03-07 |
| Probe | HXB | Class 1 | Orthopedic | No | 2007-08-09 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2011-04-18 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2002-06-19 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2002-06-01 |
| Splint, Traction | HSP | Class 1 | Orthopedic | No | 1998-09-23 |
| Bender | HXW | Class 1 | Orthopedic | No | 2000-09-08 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2002-06-06 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 2002-07-11 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 1998-09-23 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2002-06-01 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2002-03-07 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2002-06-06 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2002-06-06 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2002-03-07 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-03-13 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2002-07-11 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2007-01-29 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2007-08-09 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2002-07-11 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2017-05-06 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2002-03-07 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2002-03-07 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2002-06-19 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2002-06-01 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1998-09-23 |
| Rongeur, Mastoid | JZA | Class 1 | Ear, Nose, Throat | No | 2002-07-11 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2002-07-11 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 1978-06-20 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2002-08-21 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 1998-09-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-06-22 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2007-08-09 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 1978-06-20 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2007-12-17 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2007-08-09 |
| Erisophake | HNT | Class 1 | Ophthalmic | No | 2002-06-06 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2002-06-06 |
| Snare, Ear | JZD | Class 1 | Ear, Nose, Throat | No | 2002-06-06 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2002-06-19 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2020-04-03 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2002-06-06 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2002-03-07 |
| Clip, Aneurysm | HCH | Class 2 | Neurology | No | 2007-12-18 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2002-03-07 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2011-02-16 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2002-06-06 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2002-03-07 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 1998-09-18 |
| Remover, Crown | EIS | Class 1 | Dental | No | 1998-09-23 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2002-06-19 |
| Prosthesis, Finger, Semi-Constrained, Metal/Polymer | SFA | Class 3 | Unknown | No | 2025-07-21 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 1998-09-23 |
| Pinwheel | GWY | Class 1 | Neurology | No | 2002-07-11 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2002-06-19 |
| Probe, Rectal, Non-Powered | EXX | Class 1 | Gastroenterology, Urology | No | 2002-07-11 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2007-08-09 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2007-08-09 |
| Applier, Aneurysm Clip | HCI | Class 2 | Neurology | No | 2007-12-18 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1978-06-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2002-03-07 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2001-09-27 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2002-07-11 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2002-06-01 |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | Class 1 | Gastroenterology, Urology | No | 2007-12-18 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2007-08-09 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2007-08-09 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2011-04-20 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2002-06-19 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-04-07 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2001-02-22 |
| Curette, Periodontic | EMS | Class 1 | Dental | No | 1998-09-23 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2002-06-06 |
| Punch, Adenoid | KBS | Class 1 | Ear, Nose, Throat | No | 2002-06-01 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2002-03-07 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 2002-03-07 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2007-08-09 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 1998-09-18 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2002-04-24 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2004-12-30 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2002-07-11 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2002-06-06 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2007-08-09 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2002-03-07 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2025-04-16 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2011-04-19 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2002-07-11 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2007-08-09 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2010-02-10 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2025-03-28 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2002-07-11 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 2002-06-19 |
| Rod, Measuring Ear | JYZ | Class 1 | Ear, Nose, Throat | No | 1978-06-20 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1998-09-23 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2007-08-09 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-06-17 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2008-01-17 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 1978-06-20 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2006-06-14 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2017-02-02 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2010-12-14 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2002-07-11 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2007-08-09 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 1997-06-10 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2017-02-02 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2011-04-18 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2002-07-11 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2007-12-18 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2002-09-18 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2002-06-01 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2007-08-09 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2002-07-11 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2002-06-19 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2002-03-07 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2022-05-03 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2002-03-07 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2007-08-09 |
| Magnet, Permanent | HPN | Class 1 | Ophthalmic | No | 2002-06-19 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2017-06-17 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2002-03-07 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2007-08-09 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2002-07-11 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2007-08-09 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2002-06-01 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2025-04-16 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2002-07-11 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2002-03-07 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 1998-09-18 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2008-01-17 |
| Hook, Tonsil Suturing | KBP | Class 1 | Ear, Nose, Throat | No | 1998-09-21 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2002-03-07 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2007-08-09 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 2002-06-06 |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | Class 1 | Obstetrics/Gynecology | No | 2002-03-07 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2002-06-19 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2002-06-06 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2002-06-01 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2002-06-06 |
| Skid, Bone | HWO | Class 1 | Orthopedic | No | 2002-06-01 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2007-08-09 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 1998-09-23 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2002-03-07 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2002-06-19 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 2002-06-01 |
| Sound, Urethral, Metal Or Plastic | FBX | Class 1 | Gastroenterology, Urology | No | 2002-07-11 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2002-06-19 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2025-04-28 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2002-03-07 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 1998-09-23 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2002-07-11 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1998-09-23 |
| Cannula, Ear | JYC | Class 1 | General, Plastic Surgery | No | 2002-06-06 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2002-03-07 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2007-08-09 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1978-06-20 |
| File | HTP | Class 1 | Orthopedic | No | 2007-08-09 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 2002-07-11 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2002-06-06 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2017-04-03 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2002-06-01 |
| Punch, Attic | JYX | Class 1 | Ear, Nose, Throat | No | 2002-06-01 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Template | HWT | Class 1 | Orthopedic | No | 2011-04-18 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2002-06-06 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2002-06-06 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 1998-09-18 |
| Percussor | GWZ | Class 1 | Neurology | No | 2007-04-19 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2007-08-09 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2007-08-09 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 1978-06-20 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 1998-09-18 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2000-09-18 |
Proprietary Names
MediRod Pedicle Screw System
Magnetic Inserts
Medicon Tap
Medicon Epiplating System
Medicon
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device