FDA Device Registration & Listing · Brooksville, FL, US · Registration 3007507973
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2023-03-02 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-03-02 |
| HWI | Corkscrew | Orthopedic | Class 1 | 888.4540 | 2024-10-16 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-03-22 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-06-01 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-07-01 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2023-03-02 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-02 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-03-20 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2023-03-16 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-12-07 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-02 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-02 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| KBR | Needle, Tonsil Suturing | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-02 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2023-03-02 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2024-05-08 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2023-03-20 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | Class 2 | 882.4800 | 2023-09-15 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2023-03-01 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-02 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2023-03-02 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2023-03-02 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-10-16 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2023-03-02 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-03-02 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-15 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-02 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-29 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2023-03-16 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2025-02-10 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-03-02 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-03-02 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-01 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2023-03-20 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-03-20 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-03-02 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-02 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-09-25 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-11 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2024-06-17 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-01 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| HNM | Needle, Ophthalmic Suturing | Ophthalmic | Class 1 | 886.4350 | 2023-03-02 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-03-02 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| K820290 | The Anspach Effort, Inc. | SELF RETAINING RETRACTOR FOR HAND SURG | 1982-03-05 |
| K760422 | Cutter Laboratories, Inc. | SURGICAL RETRACTOR | 1976-08-23 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0007-2013 | Invuity, Inc. | 2 | BriteField illuminated Suction Device;
Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray.
The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. |
| Z-0039-2018 | Teleflex Medical | 1 | Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle. |
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0010-2008 | N/A | 1 | EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8010379 | DEPUY INTL., LTD. | LEEDS, GB |
| 9616671 | DEPUY (IRELAND) | CO. CORK Munster, IE |
| 3002862271 | Wenzler Medizintechnik GmbH | Frittlingen Baden-Wurttemberg, DE |
| 1926681 | JEDMED Instrument Company | Saint Louis, MO, US |
| 1424478 | Merced Medical, Inc. | Scottsdale, AZ, US |
3007507973 when referencing this establishment in official correspondence.