FDA Registration
Active
🇩🇪 Germany
KLS Martin SE & Co. KG
Reg #: 9610905
·
FEI: 3002807464
·
Expires 2026
Products
167
Proprietary Names
0
Establishment Types
1
Classifications
167
Registration Details
- Registration Name
- KLS Martin SE & Co. KG
- Registration Number
- 9610905
- FEI Number
- 3002807464
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Kolbinger StraBe 10
- City
- Muhlheim/Donau Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- KLS Martin SE & Co. KG
- Operator Number
- 10089006
- Address
- KLS Martin Platz 1
- City
- Tuttlingen
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
US Agent
- Business Name
- KLS-Martin L.P.
- Contact Name
- Melissa Bachorski
- Address
- 11201 Saint Johns Industrial Pkwy S.
- City
- JAX
- State
- FL
- ZIP
- 32246
- Country
- US
- [email protected]
- Phone
- 800 6251557 ext. 8168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2023-10-27 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2023-10-30 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-10-27 |
| Forceps, Wire Closure, Ent, Sterile | JXX | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2025-02-21 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-10-28 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2023-10-28 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Fork | HXE | Class 1 | Orthopedic | No | 2023-10-27 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Screwdriver, Skullplate | GXL | Class 1 | Neurology | No | 2025-01-16 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2023-10-27 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2023-10-27 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Battery, Replacement, Rechargeable | MOQ | Class 1 | General, Plastic Surgery | No | 2023-10-30 |
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2023-10-27 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2023-10-30 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2023-10-30 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2025-01-16 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-16 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2023-10-27 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2023-10-28 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2023-10-30 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2023-10-30 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-10-27 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2023-10-30 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2023-10-27 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2023-10-27 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2023-10-27 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2023-10-30 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2023-10-30 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2023-10-27 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2023-10-30 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Implant, Subperiosteal | ELE | Class 2 | Dental | No | 2023-10-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2023-10-27 |
| Fastener, Plate, Cranioplasty | HBW | Class 2 | Neurology | No | 2023-10-28 |
| Plate, Cranioplasty, Preformed, Alterable | GWO | Class 2 | Neurology | No | 2023-10-28 |
| Cranial Distraction System | PBJ | Class 2 | Neurology | No | 2023-11-27 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2023-10-30 |
| Bender | HXW | Class 1 | Orthopedic | No | 2023-10-27 |
| Rod, Measuring Ear | JYZ | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2023-10-30 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2023-10-27 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2023-10-27 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2023-10-30 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2023-10-30 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2023-10-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-08-25 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2025-03-24 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2026-01-13 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2023-10-27 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2023-10-27 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2023-10-28 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-07-16 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2023-10-30 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2023-10-30 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2023-10-30 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2023-10-30 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2023-10-30 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Template | HWT | Class 1 | Orthopedic | No | 2023-10-27 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2023-10-30 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2023-10-30 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2023-10-27 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2023-10-27 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2023-10-30 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2023-10-27 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2023-10-30 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2023-10-30 |
| Block, Cutting, Ent, Sterile | JXS | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Probe | HXB | Class 1 | Orthopedic | No | 2023-10-27 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2023-10-30 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2023-10-30 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2023-10-27 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2023-10-27 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 2023-10-27 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2023-10-27 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2023-10-30 |
| Scissors, Wire Cutting, Ent, Non-Sterile | NNU | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2023-10-27 |
| Cranial Surgical Planning And Instrument Guides | PPT | Class 2 | Neurology | No | 2023-10-28 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2023-10-30 |
| Prosthesis, Condyle, Mandibular, Temporary | NEI | Class 2 | Dental | No | 2023-10-27 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2023-10-27 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2023-10-30 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2023-10-30 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2023-10-30 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2023-10-30 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2023-10-30 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2023-10-30 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2023-10-30 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2023-10-30 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2023-10-30 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2023-10-30 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2023-10-30 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2023-10-28 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2023-10-27 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2023-10-27 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Dynamometer, Nonpowered | HRW | Class 1 | Orthopedic | No | 2026-03-06 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2023-10-30 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 2023-10-30 |
| Methyl Methacrylate For Cranioplasty | GXP | Class 2 | Neurology | No | 2023-10-28 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2023-10-27 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2023-10-27 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2023-10-30 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2023-10-30 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Trocar, Sinus | KBG | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-10-27 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2023-10-30 |
| Device, Locking, For Intestinal Clamp | FFR | Class 1 | Gastroenterology, Urology | No | 2023-10-30 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2023-10-27 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2023-10-27 |
| Rongeur, Mastoid | JZA | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2023-10-27 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2023-10-27 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2023-10-27 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-10-27 |
| Unit, Heating, Powered | IRQ | Class 1 | Physical Medicine | No | 2023-10-30 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2023-10-27 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)