FDA Device Registration & Listing · Beverly, MA, US · Registration 3005695838
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2024-06-21 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2021-02-22 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-06-21 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2021-02-22 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | Class 1 | 876.5090 | 2024-06-21 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2021-02-22 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-04 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-26 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2024-11-05 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2021-02-22 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2021-02-22 |
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | Class 1 | 876.4530 | 2021-02-22 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-02-22 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2025-06-04 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2021-02-22 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2021-02-22 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2021-02-22 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2021-02-22 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-02-22 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-04 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-04 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-21 |
| HOB | Clamp, Muscle, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2021-02-22 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-04 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-04 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-05 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2021-02-22 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2025-06-04 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-03-21 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2021-02-22 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2021-02-22 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2021-02-22 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2021-02-22 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 2025-06-04 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| JZE | Spoon, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-03-21 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2025-06-04 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| JZA | Rongeur, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-02-22 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-06-21 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2021-02-22 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2021-02-22 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2021-02-22 |
| HOD | Clamp, Eyelid, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2021-02-22 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-02-22 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2021-02-22 |
| KAO | Curette, Ethmoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-02-22 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2021-02-22 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2021-02-22 |
| HWR | Driver, Prosthesis | Orthopedic | Class 1 | 888.4540 | 2025-03-21 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-02-22 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K863293 | Lifestream Int'L, Inc. | DISPOSABLE SUCTION CANNULA NO. 902008-000 | 1986-09-09 |
| K914226 | E.I. Dupont DE Nemours & Co., Inc. | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | 1991-11-19 |
| 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-0034-2012 | X Spine Systems Inc | 1 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144
The Axle Torque Driver Handle is used to lock the set screw into the locking plate. |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004358587 | HURON TOOL & CUTTER GRINDING | Farmingdale, NY, US |
| 3023809973 | RUSUN MEDICAL CO., LTD | Yichun City Jiangxi, CN |
| 3008496217 | DERMATO PLASTICA BEAUTY CO., LTD. | Kaohsiung City, TW |
| 3001614464 | medi-G GMBH | Messkirch Baden-Wurttemberg, DE |
| 3028006458 | ClearPoint Neuro Inc. | Carlsbad, CA, US |
3005695838 when referencing this establishment in official correspondence.