FDA Registration
Active
🇩🇪 Germany
ACKERMANN INSTRUMENTE GMBH
Reg #: 8010273
·
FEI: 4486
·
Expires 2026
Products
58
Proprietary Names
56
Establishment Types
4
Classifications
58
Registration Details
- Registration Name
- ACKERMANN INSTRUMENTE GMBH
- Registration Number
- 8010273
- FEI Number
- 4486
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- EISENBAHNSTR. 65-67
- City
- RIETHEIM, WEILHEIM Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K153367
Owner / Operator
- Firm Name
- ACKERMANN INSTRUMENTE GMBH
- Operator Number
- 8010273
- Address
- EISENBAHNSTR. 65-67, --
- City
- RIETHEIM, WEILHEIM
- State
- Baden-Wurttemberg
- Postal Code
- 78604
- Country
- DE
US Agent
- Business Name
- Ackermann USA, Inc.
- Contact Name
- Richard Rodgers
- Address
- 592 Middle Rd
- City
- Bayport
- State
- NY
- ZIP
- 11705
- Country
- US
- [email protected]
- Phone
- 631 8683886
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2024-10-18 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2022-01-19 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2024-10-18 |
| Cannulae, Bronchial | KCE | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-07-20 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2024-10-18 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2024-12-16 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Applier, Hemostatic Clip | HBT | Class 1 | General, Plastic Surgery | No | 1996-09-26 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2023-01-17 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2020-10-19 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2014-07-02 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-03-18 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-03-18 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2023-08-25 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2024-10-18 |
| Dislodger, Stone, Flexible | FGO | Class 2 | Gastroenterology, Urology | No | 2023-02-15 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2014-07-02 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Probe | HXB | Class 1 | Orthopedic | No | 2024-10-18 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2023-03-15 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2012-11-26 |
| Mirror, General & Plastic Surgery | FTX | Class 1 | General, Plastic Surgery | No | 2025-02-17 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 1996-10-30 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2012-11-26 |
| Punch, Antrum | KAW | Class 1 | Ear, Nose, Throat | No | 2014-07-02 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2012-11-26 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-10-21 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-10-21 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2014-07-02 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1996-01-30 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2024-10-17 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2023-01-17 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1997-05-28 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2011-11-22 |
| Clip, Hemostatic | MCH | Class 2 | General, Plastic Surgery | No | 2011-11-22 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2014-07-02 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2024-10-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2023-01-17 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2014-07-02 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2023-01-17 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2014-07-02 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2023-01-17 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2014-07-02 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2023-02-23 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2014-07-02 |
| Speculum, Non-Illuminated | FXE | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2014-07-02 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2024-10-17 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2023-05-26 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2002-04-11 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 2014-07-02 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-01-31 |
Proprietary Names
SURGICAL CURETTE
Holder, Needle; Open and Endoscopic Surgery
GAUGE, MECHANICAL, GENERAL-PURPOSE
Cannula Bronchial
Ackermann Suturing Needle Instrument
SURGICAL KNIFE
PATIENT POSITIONING DEVICE
Camera Television Endoscopic Without Audio
Applier Clip
SURGICAL RETRACTOR, SELF-RETAINING
Ackermann Fusion Insufflator
Cleaner Ultrasonic Medical Instrument
Tray Surgical Instrument
Laparoscopic Instruments and Accessories
Kit Surgical Disposable
Tonsil dissector
Instrument Surgical Disposable
VAGINAL SPECULUM
Flexible Stone Basket
Cannula Surgical General & Plastic Surgery
Tube Tonsil Suction
Scissors General Surgical
PROBE, GENERAL-PURPOSE
ACKERMANN URETHROTOME
punches
Mirror, reusable hand instrument, non-sterile, general surgery
Applier , Surgical Clips
Suction Irrigation Systems
Punch Antrum
artroscopic devices, punches
Ackermann Intervertebral Body Fusion Device
Knife ENT
Dissector
Rasp
ORTHOPEDIC CUTTING INSTRUMENT
FORCEPS
Europclip
Instruments Surgical Cardiovascular
CAST / PLASTER SPREADER
SURGICAL RETRACTOR
Medical Device Data System
SURGICAL HANDLE, SCALPEL
Punch ENT
SURGICAL CLAMPS
Curette Nasal
ACKERMANN LED LIGHT SOURCE
LAPAROSCOPE
Cannula Injection
Otoscope
Speculum Non-Illuminated
Scissors Medical Disposable
SPECULUM, ENT
Ackermann Diflex System
MICROSURGICAL
Punch Nasal
Bronchoscopes
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Foreign Private Label Distributor
Repack or Relabel Medical Device