FDA Device Registration & Listing · Shanghai, CN · Registration 3009865268
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 |
|---|---|---|---|---|---|
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-02-19 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2024-01-09 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-19 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2024-02-19 |
| IMM | Footrest, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2024-02-19 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Neurology | Class 2 | 882.4300 | 2024-02-19 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-02-19 |
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | Class 2 | 882.1620 | 2024-02-19 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-02-19 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-19 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2024-02-19 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-02-19 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-02-19 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-02-19 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-02-19 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2024-02-19 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-19 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-19 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-19 |
| ISL | Joint, Hip, External Limb Component | Physical Medicine | Class 1 | 890.3420 | 2024-02-19 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2024-02-19 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-19 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-19 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2024-02-19 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2024-02-19 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-19 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K020558 | Integra Neurosciences | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE | 2002-03-21 |
| 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 |
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| K820290 | The Anspach Effort, Inc. | SELF RETAINING RETRACTOR FOR HAND SURG | 1982-03-05 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| 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 |
|---|---|---|
| 3013055490 | POPSTIX LTD | Auckland, NZ |
| 3045058049 | BOEN HEALTHCARE CO., LTD. | Suzhou Jiangsu, CN |
| 2434839 | ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. | WESTBURY, NY, US |
| 8040278 | Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, PK |
| 3013503739 | B&H SURGICAL INSTRUMENT | Sialkot Punjab, PK |
3009865268 when referencing this establishment in official correspondence.