FDA Device Registration & Listing · Sialkot Punjab, PK · Registration 3031564283
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2026-03-16 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2026-03-16 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-05-30 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| EMO | Knife, Periodontic | Dental | Class 1 | 872.4565 | 2024-05-30 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-05-30 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-31 |
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-03-16 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2026-03-16 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2024-05-30 |
| GFB | Head, Surgical, Hammer | General, Plastic Surgery | Class 1 | 878.4820 | 2026-03-16 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2024-05-31 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-30 |
| HDA | Forceps, Obstetrical | Obstetrics/Gynecology | Class 2 | 884.4400 | 2024-05-30 |
| HOF | Burr, Corneal, Manual | Ophthalmic | Class 1 | 886.4350 | 2024-05-30 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-31 |
| KCR | Facebow | Dental | Class 1 | 872.3220 | 2026-03-16 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2026-03-16 |
| EIB | Syringe, Irrigating (Dental) | Dental | Class 1 | 872.4565 | 2024-05-30 |
| HGN | Stethoscope, Fetal | Obstetrics/Gynecology | Class 1 | 884.2900 | 2026-03-16 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-30 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2024-05-30 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| KDG | Chisel (Osteotome) | General, Plastic Surgery | Class 1 | 878.4820 | 2024-05-30 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2026-03-16 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2026-03-16 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-30 |
| IZD | Probe, Uptake, Nuclear | Radiology | Class 1 | 892.1320 | 2024-05-30 |
| FXE | Speculum, Non-Illuminated | General, Plastic Surgery | Class 1 | 878.1800 | 2026-03-16 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2026-03-16 |
| JYC | Cannula, Ear | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2026-03-16 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-30 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2024-05-30 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-30 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2024-05-30 |
| DZS | Capsule, Dental, Amalgam | Dental | Class 1 | 872.3110 | 2024-05-30 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2024-05-31 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2024-05-31 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2026-03-16 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2024-05-30 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2026-03-16 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-30 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-30 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2026-03-16 |
| KCI | Trocar, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2026-03-16 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2026-03-16 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2024-05-30 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2026-03-16 |
| JZE | Spoon, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2026-03-16 |
| FXF | Speculum, Illuminated | General, Plastic Surgery | Class 1 | 878.1800 | 2026-03-16 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-05-31 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2024-05-30 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2024-05-30 |
| FFR | Device, Locking, For Intestinal Clamp | Gastroenterology, Urology | Class 1 | 876.4730 | 2026-03-16 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| NWF | Drill, Battery Powered, Subungual Hematoma | General, Plastic Surgery | Class 1 | 878.4820 | 2026-03-16 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-31 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2024-05-30 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-30 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2026-03-16 |
| GBN | Catheter, Pediatric, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4200 | 2026-03-16 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2026-03-16 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-30 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-30 |
| ECN | Clamp, Wire, Orthodontic | Dental | Class 1 | 872.5410 | 2026-03-16 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-31 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-30 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-01-24 |
| GAE | Snare, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-16 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2024-05-30 |
| JYM | Inserter, Myringotomy Tube | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-31 |
| 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 |
| K894785 | Fdt Precision Machine Co., Inc. | SURGICAL CHISEL/OSTEOTOME | 1989-08-18 |
| K942580 | Neoprobe Corp. | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | 1995-02-09 |
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 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 |
|---|---|---|
| 3012771684 | ALLURE ORTHO | Whitinsville, MA, US |
| 3009340886 | PANORAMA INTERNATIONAL. | SIALKOT Punjab, PK |
| 3008770252 | NOVO SURGICAL, INC. | Westmont, IL, US |
| 3007616048 | ZHEJIANG PROTECT MEDICAL EQUIPMENT CO. LTD. | Anji Zhejiang, CN |
| 9710113 | ORTHODONTIC MANUFACTURER SIA SRL | ROCCA D EVANDRO Caserta, IT |
3031564283 when referencing this establishment in official correspondence.