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General Hospital devices
268 product codes reviewed by the General Hospital panel. 15,652 510(k) clearances and 6,297 recalls in the FDA data, 69% of those recalls name a 510(k).
151510(k)s in 12 months
328recalls in 12 months
4,368recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 6 | 110 |
| FRN | Pump, Infusion | 2 | 2 | 24 |
| FMG | Stopcock, I.V. Set | 2 | 0 | 19 |
| FMF | Syringe, Piston | 2 | 13 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 13 | 3 |
| LRS | I.V. Start Kit | 2 | 0 | 15 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 8 | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 4 | 9 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 10 | 0 |
| FRC | Indicator, Biological Sterilization Process | 2 | 1 | 8 |
| MCY | Wound Dressing Kit | 2 | 0 | 9 |
| LLI | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use | 2 | 0 | 7 |
| FLE | Sterilizer, Steam | 2 | 5 | 1 |
| FMZ | Incubator, Neonatal | 2 | 2 | 3 |
| FRG | Wrap, Sterilization | 2 | 5 | 0 |
| LZG | Pump, Infusion, Insulin | 2 | 2 | 3 |
| PND | Midline Catheter | 2 | 1 | 4 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | 0 | 4 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 2 | 4 | 0 |
| JOL | Catheter And Tip, Suction | 2 | 0 | 4 |
| LGZ | Warmer, Thermal, Infusion Fluid | 2 | 3 | 1 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 2 | 1 | 3 |
| OWL | Peripheral Catheter Insertion Kit | 2 | 0 | 4 |
| PAD | Chest Drainage Kit | 2 | 0 | 4 |
| PXI | Thoracentesis Tray | 2 | 0 | 4 |
| FLL | Continuous Measurement Thermometer | 2 | 2 | 1 |
| KPE | Container, I.V. | 2 | 3 | 0 |
| LHI | Set, I.V. Fluid Transfer | 2 | 2 | 1 |
| MMK | Container, Sharps | 2 | 3 | 0 |
| PHC | Infusion Safety Management Software | 2 | 1 | 2 |
| QTG | Infant Supine Sleep System | 2 | 0 | 3 |
| SDC | Qualitative Cleaning Process Protein Indicator | 2 | 1 | 2 |
| FMT | Warmer, Infant Radiant | 2 | 0 | 2 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 2 | 0 | 2 |
| FPO | Stretcher, Wheeled | 2 | 0 | 2 |
| FQH | Lavage, Jet | 2 | 2 | 0 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 1 | 1 |
| MEC | Disinfector, Medical Devices | 2 | 0 | 2 |
| MED | Sterilant, Medical Devices | 2 | 2 | 0 |
| MEG | Syringe, Antistick | 2 | 2 | 0 |
| MLR | Sterilizer, Chemical | 2 | 2 | 0 |
| NEP | System/Device, Pharmacy Compounding | 2 | 0 | 2 |
| NGT | Saline, Vascular Access Flush | 2 | 1 | 1 |
| OKE | Port Introducer Kit | 2 | 0 | 2 |
| PTI | Non-Coring (Huber) Needle | 2 | 2 | 0 |
| QBP | Cap, Device Disinfectant | 2 | 2 | 0 |
| QVB | Biological Sterilization Indicator With Indirect Growth Detection | 2 | 2 | 0 |
| SCS | Ultraviolet Radiation Disinfection Chamber Device | 2 | 2 | 0 |
| CAK | Microfilter, Blood Transfusion | 2 | 0 | 1 |
| FMS | Bed, Pediatric Open Hospital | 2 | 0 | 1 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 2 | 0 | 1 |
| FPB | Filter, Infusion Line | 2 | 1 | 0 |
| FRF | Cleaner, Air, Medical Recirculating | 2 | 1 | 0 |
| GAG | Stapler, Surgical | 2 | 1 | 0 |
| LBI | Unit, Neonatal Phototherapy | 2 | 1 | 0 |
| LGM | Chamber, Patient Isolation | 2 | 1 | 0 |
| LZH | Pump, Infusion, Enteral | 2 | 1 | 0 |
| MEB | Pump, Infusion, Elastomeric | 2 | 1 | 0 |
| MRH | Pump, Infusion, Ophthalmic | 2 | 1 | 0 |
| OJA | Intravenous Extension Tubing Set | 2 | 0 | 1 |
| OPP | Pump, Infusion, Insulin Bolus | 2 | 1 | 0 |
| OSI | Bariatric Bed | 2 | 0 | 1 |
| PBZ | Image Processing Device For Estimation Of External Blood Loss | 2 | 1 | 0 |
| PKP | Immunoglobulin G (Igg) Infusion System | 2 | 1 | 0 |
| PQH | Iodinated Contrast Media Transfer Tubing Set | 2 | 1 | 0 |
| PWR | Catheter Repair Kit | 2 | 0 | 1 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | 2 | 0 | 1 |
| PXB | Percutaneous Introducer Kit | 2 | 0 | 1 |
| QLY | Ophthalmic Syringe | 2 | 1 | 0 |
| QNQ | Low Dead Space Piston Syringe | 2 | 1 | 0 |
| QXQ | Respiratory Accessory Microbial Reduction Device. | 2 | 1 | 0 |
| QYM | Ophthalmic Needle | 2 | 1 | 0 |
| SAK | Software Device To Aid In The Prediction Or Diagnosis Of Sepsis | 2 | 1 | 0 |
| SCL | Allergen And Vaccine Delivery Needles | 2 | 1 | 0 |
| SEW | Automated Endoscope Channel Cleaner | 2 | 1 | 0 |
| SGX | Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves | 2 | 1 | 0 |
| SHM | Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe | 2 | 1 | 0 |
| SIW | Robotic Peripheral Venous Blood Collection System | 2 | 1 | 0 |
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