FDA Device Registration & Listing · Fridingen Baden-Wurttemberg, DE · Registration 3036795921
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2023-10-27 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2023-10-30 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2023-10-27 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2023-10-30 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2023-10-30 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-27 |
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | Class 1 | 876.4530 | 2023-10-27 |
| JXS | Block, Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2023-10-30 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-10-30 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| JZA | Rongeur, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2023-10-30 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2023-10-30 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2023-10-27 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-10-30 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2023-10-30 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| JYZ | Rod, Measuring Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2023-10-27 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2023-10-27 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| KBM | Dissector, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-27 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-10-27 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2023-10-27 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2023-10-30 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2023-10-30 |
| HXE | Fork | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2023-10-27 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-10-27 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2023-10-30 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2023-10-30 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2023-10-27 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| KAQ | Gouge, Nasal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-10-30 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2023-10-27 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-27 |
| JXX | Forceps, Wire Closure, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2023-10-27 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-10-30 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-30 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2023-10-30 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2023-10-27 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9681383 | KLS Martin SE & Co. KG | Freiburg Baden-Wurttemberg, DE |
| 3014201171 | KLS Martin Malaysia Sdn. Bhd. | Simpang Ampat Pulau Pinang, MY |
| 9610905 | KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, DE |
| 1057946 | KLS-Martin L.P. | Jacksonville, FL, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 |
| K851721 | Artiberia | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | 1985-07-02 |
| K143738 | Intuit Medical Products, LLC | DSS Sinusplasty Balloon Catheter | 2015-08-27 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0013-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0014-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0015-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0016-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0017-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3010707607 | KARL STORZ SE & CO. KG | NEUHAUSEN OBECK Baden-Wurttemberg, DE |
| 3000264417 | Moria S.A | Bourbon l'Archambault Allier, FR |
| 8010168 | GEOMED MEDIZIN-TECHNIK GMBH & CO. KG | TUTTLINGEN Baden-Wurttemberg, DE |
| 3002108226 | SPIEGELBERG GmbH & Co. KG | Hamburg, DE |
| 9610617 | KARL STORZ SE & CO. KG | TUTTLINGEN Baden-Wurttemberg, DE |
3036795921 when referencing this establishment in official correspondence.