FDA Device Registration & Listing · Palmetto, FL, US · Registration 3012267976
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2023-08-31 |
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | Class 1 | 876.5520 | 2025-05-20 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-02-17 |
| FAX | Bougie, Urological | Gastroenterology, Urology | Class 1 | 876.5520 | 2024-11-26 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2017-01-31 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2023-12-07 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2026-05-13 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2026-05-13 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2017-01-31 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-07-20 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-07-20 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2023-12-07 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2023-07-20 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2025-05-20 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2017-01-31 |
| HNJ | Punch, Corneo-Scleral | Ophthalmic | Class 1 | 886.4350 | 2025-02-17 |
| EZB | Stylet For Catheter, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.5130 | 2023-08-31 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-26 |
| NWV | Laparoscopic Accessories, Gynecologic | Obstetrics/Gynecology | Class 1 | 884.1720 | 2023-08-31 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-02-17 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-12-07 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-11 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-02-17 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-02-17 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2026-05-13 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2024-11-26 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-12-07 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2023-07-20 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2023-12-07 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-07-20 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2024-05-30 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-07-20 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2024-04-08 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2023-12-07 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2017-01-31 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-09-18 |
| FHR | Needle, Gastro-Urology | General, Plastic Surgery | Class 1 | 878.4800 | 2026-05-13 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2023-12-07 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2024-11-26 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2017-01-31 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-09 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2026-05-13 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-02-17 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2017-01-31 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2017-01-31 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2024-12-23 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2023-12-07 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2026-05-13 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2025-05-20 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2017-01-31 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2023-08-31 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2026-05-13 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2017-01-31 |
No US Agent registered (Local establishment).
| 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 |
| K871646 | Ocular Instruments, Inc. | TANNE CORNEAL CUTTING BLOCK | 1987-05-18 |
| K854401 | Microsurgical Technology, Inc. | THE NEW MOBILE TIP MCINTYRE CANNULA | 1985-12-30 |
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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-0010-2008 | N/A | 1 | EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758. |
| Z-0011-2019 | Ellex iScience, Inc. | 1 | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery. |
| Z-0022-2009 | Becton Dickinson and Company | 1 | BD Visitec High Viscosity Injector, 4mm
Ref: 585173. The product is intended for Vitroretinal Surgery. |
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007389672 | FRANKO SHEHZAD SURGICO PVT LTD. | Sialkot Punjab, PK |
| 3011499367 | HAZEL ENTERPRISES | Sialkot Punjab, PK |
| 3022748632 | TAURUS Medizintechnik GmbH | Fridingen an der Donau Baden-Wurttemberg, DE |
| 8040179 | BASHIR JAMIL & BROTHERS (PVT.), LTD. | Sialkot Punjab, PK |
| 2087382 | DG Instruments | GRANTS PASS, OR, US |
3012267976 when referencing this establishment in official correspondence.