FDA Device Registration & Listing · SHARJAH Ash Shariqah, AE · Registration 9710524
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2008-10-22 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2009-08-30 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-09-25 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2013-09-27 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-09-11 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-03-27 |
| HAE | Rongeur, Manual | Neurology | Class 2 | 882.4840 | 2017-07-07 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 2013-06-27 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2006-07-26 |
| GWZ | Percussor | Neurology | Class 1 | 882.1700 | 2001-07-17 |
| HCZ | Forceps, Surgical, Gynecological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2014-04-16 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2013-06-27 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | Class 2 | 882.4800 | 2014-10-13 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-24 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 1981-12-10 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2001-07-17 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-24 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2013-03-26 |
| HDC | Tenaculum, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2013-05-15 |
| HTP | File | Orthopedic | Class 1 | 888.4540 | 2013-03-26 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2001-07-17 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2007-09-11 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-01-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-09-18 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2001-07-17 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-01-24 |
| KCI | Trocar, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-03-22 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2007-08-28 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-07-17 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2014-10-20 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2001-07-17 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | Class 1 | 876.5090 | 2013-03-22 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2006-08-08 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2006-09-25 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-24 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2006-08-08 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2006-09-25 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2006-08-08 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-11-15 |
| KDG | Chisel (Osteotome) | General, Plastic Surgery | Class 1 | 878.4820 | 2006-08-08 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| EXX | Probe, Rectal, Non-Powered | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-01-24 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-09-11 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| HDC | Tenaculum, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2009-01-21 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | Obstetrics/Gynecology | Class 2 | 884.4530 | 2013-05-15 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-03-22 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2007-09-11 |
| HWO | Skid, Bone | Orthopedic | Class 1 | 888.4540 | 2014-02-25 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| HAE | Rongeur, Manual | Neurology | Class 2 | 882.4840 | 2014-10-13 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-02-22 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 1981-12-10 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-09-11 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-03-27 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2023-03-28 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2006-09-25 |
| KTI | Bronchoscope Accessory | Ear, Nose, Throat | Class 2 | 874.4680 | 2013-03-28 |
| FKK | Clamp, Line | Gastroenterology, Urology | Class 1 | 876.4730 | 2014-05-17 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2001-07-17 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-09-11 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2006-09-25 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2006-08-08 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-08-28 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4420 | 2022-01-27 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1981-12-10 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2008-07-09 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2013-03-25 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2006-11-09 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2009-08-30 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2003-09-09 |
| FTX | Mirror, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-08-28 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-24 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2015-02-25 |
| HAE | Rongeur, Manual | Neurology | Class 2 | 882.4840 | 2018-07-21 |
| HBT | Applier, Hemostatic Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2013-06-17 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2013-03-22 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-08-28 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2013-02-15 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2013-06-25 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2009-08-30 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2013-05-14 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2013-06-27 |
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | Class 1 | 878.4950 | 2013-03-25 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2013-01-24 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2008-06-24 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 1981-12-10 |
| KBE | Snare, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-03-22 |
| DWP | Dilator, Vessel, Surgical | Cardiovascular | Class 2 | 870.4475 | 2013-03-28 |
| KAW | Punch, Antrum | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-12-11 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2010-03-09 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2001-07-17 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-16 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-24 |
| HDA | Forceps, Obstetrical | Obstetrics/Gynecology | Class 2 | 884.4400 | 2023-12-04 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2013-03-27 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2013-01-24 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2009-08-30 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2010-03-09 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2018-03-13 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-03-25 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2013-06-27 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2013-02-27 |
| GAH | Stylet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-03-27 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2014-11-10 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1981-12-10 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-03-27 |
| GEJ | Carrier, Ligature | General, Plastic Surgery | Class 1 | 878.4800 | 2013-03-25 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-24 |
| NGY | Cannula, Trocar, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2017-04-03 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2013-05-15 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2009-08-30 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2013-03-25 |
| HDM | Packer, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 1999-03-16 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-03-22 |
| MZY | Graft, Vascular, Stainless Steel Tunneler | Cardiovascular | Class 2 | 870.3450 | 2013-03-28 |
| HFX | Clamp, Circumcision | Obstetrics/Gynecology | Class 2 | 884.4530 | 2022-11-23 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 1981-12-10 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2007-09-11 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2001-07-17 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2013-03-25 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-03-12 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2001-07-17 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 1981-12-10 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 2006-08-08 |
| DSS | Clip, Vascular | Cardiovascular | Class 2 | 870.3250 | 2013-05-15 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2009-08-30 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2013-06-27 |
| DWQ | Stripper, Vein, External | Cardiovascular | Class 2 | 870.4885 | 2013-02-15 |
| GCF | Proctoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-27 |
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | Class 1 | 876.5520 | 2006-08-08 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2006-08-08 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-09-11 |
| DQR | Cannula, Catheter | Cardiovascular | Class 2 | 870.1300 | 2014-02-25 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2013-01-24 |
| EIA | Unit, Operative Dental | Dental | Class 1 | 872.6640 | 2013-07-02 |
| KTR | Tube, Aspirating, Bronchoscope, Rigid | Ear, Nose, Throat | Class 2 | 874.4680 | 2013-05-15 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2007-09-11 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2001-07-17 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2007-09-11 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-20 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2013-03-27 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2007-09-11 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2006-11-09 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2001-07-17 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2013-09-12 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8040233 | QSA SURGICAL (PVT) LTD. | SIALKOT Punjab, PK |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K914997 | Conmedcorp | ASP-IRRATOR | 1992-01-07 |
| K153773 | Olympus Medical Systems Corp. | Disposal Lens Cleaning Sheath | 2016-11-22 |
| K940141 | Micro-Medical Devices, Inc. | LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH | 1994-05-19 |
| K933812 | Advanced Surgical, Inc. | ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES | 1993-12-13 |
| K254228 | Karl Storz SE & CO. KG | KARL STORZ Trocars with Valve Seals | 2026-05-11 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. |
| Z-0028-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures. |
| Z-0029-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled
(2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures. |
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| 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 |
|---|---|---|
| 9610612 | AESCULAP AG | TUTTLINGEN, DONAU Baden-Wurttemberg, DE |
| 9616250 | ASANUS MEDIZINTECHNIK GMBH | NEUHAUSEN OBECK Baden-Wurttemberg, DE |
| 3003244954 | ZEPF MEDICAL INSTRUMENTS GMBH | SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE |
| 3003807268 | HIVE INTERNATIONAL PVT LTD. | Sialkot Punjab, PK |
| 3003644849 | DR. FRIGZ INTERNATIONAL (PVT) LTD. | SIALKOT, Punjab, PK |
9710524 when referencing this establishment in official correspondence.