FDA Device Registration & Listing · Sialkot Punjab, PK · Registration 3016965929
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2023-09-13 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-07 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-29 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2023-01-28 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2025-06-29 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-28 |
| HBS | Instrument, Clip Forming/Cutting | Neurology | Class 1 | 882.4190 | 2025-06-29 |
| GFB | Head, Surgical, Hammer | General, Plastic Surgery | Class 1 | 878.4820 | 2025-06-28 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 2023-09-13 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2023-09-13 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2022-11-23 |
| FFP | Dilator, Rectal | Gastroenterology, Urology | Class 1 | 876.5450 | 2025-06-30 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2025-06-29 |
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | Class 1 | 876.4530 | 2025-06-28 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2023-09-20 |
| EYJ | Holder, Ureteral Catheter | Gastroenterology, Urology | Class 1 | 876.5130 | 2025-06-30 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2022-12-13 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-23 |
| KCX | Epilator, High Frequency, Tweezer-Type | General, Plastic Surgery | Class 1 | 878.5360 | 2022-03-26 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2025-06-29 |
| EIB | Syringe, Irrigating (Dental) | Dental | Class 1 | 872.4565 | 2023-09-13 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2025-06-29 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-09-29 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-28 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 2025-06-28 |
| JXX | Forceps, Wire Closure, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2025-06-29 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-28 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-29 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-28 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2022-03-27 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2025-06-29 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2023-09-20 |
| EKG | Condenser, Amalgam And Foil, Operative | Dental | Class 1 | 872.4565 | 2024-03-27 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2023-09-29 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2023-09-13 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-06-29 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2023-01-28 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 2025-06-28 |
| EKE | Curette, Operative | Dental | Class 1 | 872.4565 | 2023-09-20 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-13 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-29 |
| ECT | Driver, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2025-08-06 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2023-09-20 |
| OOW | Applicator For Rectal Suppository | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-06-30 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2022-03-26 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2023-09-20 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2025-08-06 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-29 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-20 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-06-29 |
| BWB | Forceps, Tube Introduction | Anesthesiology | Class 1 | 868.5780 | 2025-06-28 |
| DZC | Wire, Orthodontic | Dental | Class 1 | 872.5410 | 2025-06-28 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2023-07-06 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2023-09-20 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2023-09-13 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-28 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-09-29 |
| FTX | Mirror, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-29 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2025-06-29 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-28 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-20 |
| BZS | Stethoscope Head | Anesthesiology | Class 1 | 868.1930 | 2025-06-28 |
| FFR | Device, Locking, For Intestinal Clamp | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-06-30 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2022-03-26 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2025-06-29 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-09-20 |
| HOD | Clamp, Eyelid, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-06-29 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2023-09-13 |
| HNK | Probe, Trabeculotomy | Ophthalmic | Class 1 | 886.4350 | 2025-06-29 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-20 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-29 |
| BZW | Stethoscope, Esophageal | Anesthesiology | Class 1 | 868.1910 | 2025-06-28 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-20 |
| EJE | Frame, Rubber Dam | Dental | Class 1 | 872.6300 | 2023-09-20 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2023-09-29 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2024-05-07 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2025-06-29 |
| EGZ | Holder, Film, X-Ray | Dental | Class 1 | 872.1905 | 2025-06-30 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-29 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2023-09-20 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-09-29 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2023-09-29 |
| FKK | Clamp, Line | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-06-29 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2023-09-29 |
| DZA | Drill, Dental, Intraoral | Dental | Class 1 | 872.4130 | 2022-03-24 |
| EJZ | Knife, Margin Finishing, Operative | Dental | Class 1 | 872.4565 | 2025-06-28 |
| JYF | Clamp, Ossicle Holding | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-29 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-28 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-06-29 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-29 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-06-30 |
| FFF | Cover, Biopsy Forceps | Gastroenterology, Urology | Class 1 | 876.1075 | 2025-06-28 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2023-09-20 |
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2023-05-23 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2025-06-29 |
| LRZ | Screwdriver, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-08-06 |
| JZA | Rongeur, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-05-23 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-28 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-06-29 |
| EMR | File, Periodontic | Dental | Class 1 | 872.4565 | 2023-09-13 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2022-11-25 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-20 |
| NNQ | Forceps, Wire Closure, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2025-06-29 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2022-12-02 |
| EMO | Knife, Periodontic | Dental | Class 1 | 872.4565 | 2023-09-13 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-29 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2025-06-29 |
| HBQ | Instrument, Clip Removal | Neurology | Class 1 | 882.4200 | 2025-06-29 |
| MXP | Bone Particle Collector | Ear, Nose, Throat | Class 1 | 874.4800 | 2022-12-02 |
| HDA | Forceps, Obstetrical | Obstetrics/Gynecology | Class 2 | 884.4400 | 2025-06-29 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-09-20 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-09-29 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2022-12-02 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2022-12-02 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-29 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-06-28 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-09-29 |
| FSH | Tray, Surgical, Needle | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-29 |
| HOB | Clamp, Muscle, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-06-29 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| 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 |
| K112640 | Ormco Corp. | HYPERELASTIC WIRE | 2011-11-16 |
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| 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-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| 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-0040-2018 | Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446 | 1 | Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System
The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9613926 | Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, IN |
| 8010732 | Kohler Medizintechnik GmbH | STOCKACH Baden-Wurttemberg, DE |
| 3008711893 | B.Braun Medical (Suzhou) Co,.Ltd | Suzhou Jiangsu, CN |
| 1646747 | WEXLER SURGICAL, INC. | HOUSTON, TX, US |
| 3010687973 | FETZER SURGICAL, LLC | Scottsdale, AZ, US |
3016965929 when referencing this establishment in official correspondence.