FDA Device Registration & Listing · DEBRECEN Hajdu-Bihar, HU · Registration 9680519
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2023-11-07 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-06-21 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-03-19 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 1994-02-09 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1994-02-09 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2017-02-28 |
| KAY | Punch, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-06-22 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | Obstetrics/Gynecology | Class 1 | 884.4530 | 2022-09-28 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 1994-02-09 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2022-06-21 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2022-01-04 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2022-10-21 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2009-10-16 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2016-01-12 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2022-09-28 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-11-23 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2017-02-28 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2017-06-29 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2023-11-07 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2017-02-28 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2023-11-07 |
| JZY | Knife, Laryngeal | Ear, Nose, Throat | Class 1 | 874.4420 | 2017-06-29 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2017-02-28 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 1994-02-09 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2001-08-21 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-06-22 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 1994-02-09 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2010-01-21 |
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2021-06-22 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2009-09-23 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2020-06-24 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-06-22 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2021-03-24 |
| HRB | Microscope, Operating, Non-Electric, Ophthalmic | General, Plastic Surgery | Class 1 | 878.4700 | 2018-11-07 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2021-03-24 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-06-22 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2017-02-28 |
| JYK | Holder, Ear Speculum | General, Plastic Surgery | Class 1 | 878.1800 | 2021-06-22 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2017-07-27 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2010-03-02 |
| KBM | Dissector, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-06-22 |
| KBQ | Knife, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2017-05-25 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2010-03-02 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 1994-02-09 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-11-07 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2020-06-24 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2021-02-19 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-06-22 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2010-05-31 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2019-02-21 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-06-22 |
| HDM | Packer, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2010-03-02 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2022-06-21 |
| HDE | Hook, Fibroid, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4520 | 2010-03-04 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2010-03-02 |
| JYP | Knife, Myringotomy | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-09-28 |
| HDG | Speculum, Vaginal, Metal, Fiberoptic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2018-03-02 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-09-28 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1994-02-09 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2010-03-02 |
| HCZ | Forceps, Surgical, Gynecological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2010-03-04 |
| HSO | Saw | General, Plastic Surgery | Class 1 | 878.4800 | 2020-10-13 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2017-06-19 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-11-07 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2010-03-02 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| 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 |
| 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-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Z-0010-2007 | Smith & Nephew Inc | 1 | Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486 |
| Z-0011-06 | Stryker Howmedica Osteonics Corp. | 1 | Allocraft TLIF Bone Inserter. |
| Z-0011-2007 | Smith & Nephew Inc | 1 | Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105 |
| Z-0013-2011 | Depuy Orthopaedics, Inc. | 1 | Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143
Catalog Number: 2570-00-000
The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007031057 | MERCIAN SURGICAL SUPPLY CO LTD | Bromsgrove Worcestershire, GB |
| 3011693567 | LAMINATE MEDICAL TECHNOLOGIES | Tel Aviv, IL |
| 3009134882 | DMED | Seongnam-si Gyeonggi, KR |
| 1057425 | SOUTHEASTERN TECHNOLOGY dba Autocam Medical | Murfreesboro, TN, US |
| 8044098 | HGR INSTRUMENTE GMBH | TUTTLINGEN Baden-Wurttemberg, DE |
9680519 when referencing this establishment in official correspondence.