FDA Device Registration & Listing · Sialkot Punjab, PK · Registration 3008338766
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2017-10-18 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2011-12-26 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-06-07 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2016-07-20 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2011-12-26 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2011-12-26 |
| JYJ | Gauge, Measuring | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-19 |
| EIK | Carver, Wax, Dental | Dental | Class 1 | 872.4565 | 2011-12-26 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2016-08-19 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-18 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2011-12-26 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2011-12-26 |
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | Class 1 | 868.6810 | 2016-08-18 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-06-07 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-18 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2011-12-26 |
| KAG | Holder, Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2011-12-26 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2016-08-18 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2016-06-07 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2011-12-26 |
| KCM | Dropper, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2017-06-05 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2016-08-18 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2016-08-18 |
| HGD | Applicator, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-08-18 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2011-12-26 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2011-12-26 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-19 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2017-05-20 |
| EME | Punch, Biopsy, Surgical | Dental | Class 1 | 872.4565 | 2016-08-18 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2016-08-18 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2016-08-18 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-18 |
| HFX | Clamp, Circumcision | Obstetrics/Gynecology | Class 2 | 884.4530 | 2016-12-09 |
| GEE | Brush, Biopsy, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2016-08-18 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-16 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2016-08-18 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2011-12-26 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2017-05-30 |
| JXX | Forceps, Wire Closure, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2016-08-18 |
| KCP | Syringe, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2016-08-18 |
| KDG | Chisel (Osteotome) | General, Plastic Surgery | Class 1 | 878.4820 | 2016-08-18 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2016-08-18 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2016-08-18 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2016-08-18 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2011-12-26 |
| HBR | Rack, Clip | Neurology | Class 1 | 882.4215 | 2016-07-20 |
| HER | Pelvimeter, External | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-08-18 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2016-08-18 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2011-12-26 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-19 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-19 |
| FFR | Device, Locking, For Intestinal Clamp | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-08-18 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | Class 1 | 862.2050 | 2016-06-07 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-06-07 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-18 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2011-12-26 |
| HGN | Stethoscope, Fetal | Obstetrics/Gynecology | Class 1 | 884.2900 | 2016-08-19 |
| BWB | Forceps, Tube Introduction | Anesthesiology | Class 1 | 868.5780 | 2016-08-18 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2011-12-26 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2016-08-18 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-06-07 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-16 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-08-19 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-08-18 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2011-12-26 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2011-12-26 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2011-12-26 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-06-07 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-07-01 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2016-08-18 |
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2016-08-18 |
| JYC | Cannula, Ear | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2016-07-20 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2016-06-07 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2011-12-26 |
| EFK | Forceps, Articulation Paper | Dental | Class 1 | 872.4565 | 2016-08-18 |
| GWZ | Percussor | Neurology | Class 1 | 882.1700 | 2016-07-20 |
| HED | Douche Apparatus, Vaginal, Therapeutic | Obstetrics/Gynecology | Class 1 | 884.5900 | 2016-08-18 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2016-08-18 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-18 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | Class 2 | 886.1570 | 2025-09-24 |
| KAR | Irrigator, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-18 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-08-18 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2016-08-18 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2011-12-26 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2016-08-19 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2016-08-24 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2011-12-26 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-08-18 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2011-12-26 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2016-08-18 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-08-18 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2011-12-26 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-19 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2011-12-26 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-06-07 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-01-05 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2016-08-19 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-08-18 |
| FFP | Dilator, Rectal | Gastroenterology, Urology | Class 1 | 876.5450 | 2016-08-18 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2011-12-26 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-16 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2011-12-26 |
| HNA | Spud, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-08-18 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2011-12-26 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-06-08 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2016-08-18 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-18 |
| IKW | Utensil, Homemaking | Physical Medicine | Class 1 | 890.5050 | 2016-08-18 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2021-11-15 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-08-18 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-08-18 |
| IDL | Microtome, Accessories | Pathology | Class 1 | 864.3010 | 2017-10-18 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K881095 | CooperVision, Inc. | KOI(TM) INSTRUMENT TRAYS | 1988-04-06 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K143738 | Intuit Medical Products, LLC | DSS Sinusplasty Balloon Catheter | 2015-08-27 |
| K834189 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #7 44/47 | 1984-03-06 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0144-2024 | Covidien | 1 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 |
| Z-0168-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only |
| Z-0169-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9611102 | RICHARD WOLF GMBH | KNITTLINGEN Baden-Wurttemberg, DE |
| 8040278 | Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, PK |
| 9614986 | OTTO LEIBINGER GMBH | MUEHLHEIM Baden-Wurttemberg, DE |
| 3010041511 | Teleflex LLC (NADC) | Olive Branch, MS, US |
| 3032747418 | HEXAMED PVT LTD | Sialkot Punjab, PK |
3008338766 when referencing this establishment in official correspondence.