FDA Device Registration & Listing · Sialkot Punjab, PK · Registration 3011371465
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-02-10 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-02-10 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2016-02-10 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-02-10 |
| HDH | Needle, Cerclage, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-02-10 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2016-02-09 |
| QKR | Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Unknown | Class N | N/A | 2021-02-11 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2016-02-11 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2021-02-10 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-02-10 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-02-10 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2016-02-10 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2016-02-09 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-02-10 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2016-11-03 |
| FXF | Speculum, Illuminated | General, Plastic Surgery | Class 1 | 878.1800 | 2016-02-10 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2016-02-11 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-02-10 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2016-02-10 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | Class 1 | 868.5110 | 2016-11-03 |
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | Class 1 | 886.4335 | 2016-02-11 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-02-10 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2021-02-10 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2016-02-10 |
| GEE | Brush, Biopsy, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2016-02-10 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-02-10 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-02-10 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2016-02-10 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2016-02-10 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2016-02-09 |
| HMR | Marker, Ocular | Ophthalmic | Class 1 | 886.4570 | 2016-02-10 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| HDG | Speculum, Vaginal, Metal, Fiberoptic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-02-10 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-02-10 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2016-02-09 |
| ISN | Cable | Physical Medicine | Class 1 | 890.3420 | 2016-02-11 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-02-10 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2016-02-09 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2016-02-10 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2016-02-09 |
| KCI | Trocar, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| GAH | Stylet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2016-02-11 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-11 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2016-02-10 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-02-10 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-02-10 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2016-02-10 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-02-11 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| 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 |
| K881095 | CooperVision, Inc. | KOI(TM) INSTRUMENT TRAYS | 1988-04-06 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0002-2014 | King Systems Corp. | 1 | King LTS-D Oropharyngeal Airways
Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. |
| Z-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| 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-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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005695838 | ANMUTH MEDICAL INTERNATIONAL LLC | Beverly, MA, US |
| 3003644849 | DR. FRIGZ INTERNATIONAL (PVT) LTD. | SIALKOT, Punjab, PK |
| 9612074 | GIMMI GMBH | TUTTLINGEN Baden-Wurttemberg, DE |
| 3013846070 | GREENS SURGICALS PRIVATE LIMITED | Vadodara Gujarat, IN |
| 3023657851 | INKA SURGICAL INSTRUMENTS | Jandakot Western Australia, AU |
3011371465 when referencing this establishment in official correspondence.