FDA Device Registration & Listing · Sialkot Punjab, PK · Registration 3006487092
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-04-15 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2013-04-15 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2016-03-05 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2008-12-31 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2008-12-31 |
| EKD | Instrument, Cutting, Operative | Dental | Class 1 | 872.4565 | 2013-01-18 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2013-04-15 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2008-12-31 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2013-01-18 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2013-03-30 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-04-15 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-04-15 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-05-07 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2008-12-31 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-04-15 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2013-04-15 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2013-05-07 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2013-01-18 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2008-12-31 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2013-03-30 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2016-03-05 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2008-12-31 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2013-01-18 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2008-12-31 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2008-12-31 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2008-12-31 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-07 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2008-12-31 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2013-04-15 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2008-12-31 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2013-03-30 |
| FCZ | Tube, Smoke Removal, Endoscopic | Gastroenterology, Urology | Class 1 | 876.1500 | 2013-04-15 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-04-15 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-04-15 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-02-25 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-03-05 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2013-04-15 |
| EKE | Curette, Operative | Dental | Class 1 | 872.4565 | 2013-03-30 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2008-12-31 |
| HWO | Skid, Bone | Orthopedic | Class 1 | 888.4540 | 2008-12-31 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2008-12-31 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-07 |
No official correspondent registered.
| 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 |
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 |
| 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-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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3043533459 | RC CONSOLIDATED SERVICES, INC | Rancho Cucamonga, CA, US |
| 3003431869 | HILBRO INTERNATIONAL (PVT) LIMITED | SIALKOT Punjab, PK |
| 8010769 | KAPP SURGICAL GMBH | DUERBHEIM Baden-Wurttemberg, DE |
| 3005067367 | SHANGHAI MEDICAL INSTRUMENTS (GROUP) LTD. CORP. | Shanghai, CN |
| 3010041511 | Teleflex LLC (NADC) | Olive Branch, MS, US |
3006487092 when referencing this establishment in official correspondence.