| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| FIW | Alarm, Pillow Pressure | 第 2 类 | 21 CFR 876.5820 | 1 |
| FIZ | Meter, Conductivity, Non-Remote | 第 2 类 | 21 CFR 876.5820 | 13 |
| FJA | Manometer, Water | 第 2 类 | 21 CFR 876.5820 | |
| FJB | Detector, Dialysate Level | 第 2 类 | 21 CFR 876.5820 | 3 |
| FJC | Detector, Blood Level | 第 2 类 | 21 CFR 876.5820 | 1 |
| FJD | Detector, Leak, Blood | 第 2 类 | 21 CFR 876.5820 | 4 |
| FJF | Detector, Air Bubble | 第 2 类 | 21 CFR 876.5820 | 5 |
| FJG | Dialyzer, Parallel Flow | 第 2 类 | 21 CFR 876.5820 | 36 |
| FJH | Dialyzer, Disposable | 第 2 类 | 21 CFR 876.5830 | 4 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 第 2 类 | 21 CFR 876.5820 | 131 |
| FJJ | Dialyzer, Twin Coil | 第 2 类 | 21 CFR 876.5820 | |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 第 2 类 | 21 CFR 876.5820 | 77 |
| FJL | Resectoscope | 第 2 类 | 21 CFR 876.1500 | 24 |
| FJM | Guard, Shunt | 第 2 类 | 21 CFR 876.5540 | |
| FJN | Stabilizer, Shunt | 第 2 类 | 21 CFR 876.5540 | |
| FJO | Plier, Tube | 第 1 类 | 21 CFR 876.5540 | |
| FJP | Adaptor, Y | 第 2 类 | 21 CFR 876.5820 | |
| FJQ | Connector, Shunt | 第 1 类 | 21 CFR 876.5540 | 3 |
| FJR | Forceps, Disconnect | 第 1 类 | 21 CFR 876.5540 | |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 第 2 类 | 21 CFR 876.5630 | 48 |
| FJT | Intracatheter, Dialysis | 第 2 类 | 21 CFR 876.5820 | 5 |
| FJW | Ring, Joint | 第 1 类 | 21 CFR 876.5540 | |
| FJX | Ring, Crimp | 第 1 类 | 21 CFR 876.5540 | |
| FJY | Plier, Crimp | 第 1 类 | 21 CFR 876.5540 | |
| FJZ | Declotting Tray, Kit (Including Contents) | 第 2 类 | 21 CFR 876.5820 | 3 |
| FKA | Dilator, Vessel | 第 2 类 | 21 CFR 876.5540 | 3 |
| FKB | Connector, Blood Tubing, Infusion T | 第 2 类 | 21 CFR 876.5820 | 2 |
| FKC | Clamp, Cannula | 第 1 类 | 21 CFR 876.5540 | 1 |
| FKD | Canister, Coil | 第 2 类 | 21 CFR 876.5820 | 1 |
| FKE | Tie, Dialysis | 第 1 类 | 21 CFR 876.5820 | |
| FKF | Gun, Tie, Dialysis | 第 1 类 | 21 CFR 876.5820 | |
| FKG | Tray, Start/Stop (Including Contents), Dialysis | 第 1 类 | 21 CFR 876.5820 | 6 |
| FKH | Solution-Test Standard-Conductivity, Dialysis | 第 2 类 | 21 CFR 876.5820 | 8 |
| FKI | Set, Dialyzer Holder | 第 2 类 | 21 CFR 876.5820 | 3 |
| FKJ | Filter, Blood, Dialysis | 第 2 类 | 21 CFR 876.5820 | 5 |
| FKK | Clamp, Line | 第 1 类 | 21 CFR 876.4730 | 6 |
| FKL | Insert, Pump, Blood | 第 2 类 | 21 CFR 876.5820 | 1 |
| FKM | Adaptor, Fistula | 第 2 类 | 21 CFR 876.5820 | |
| FKN | Adaptor, Shunt | 第 2 类 | 21 CFR 876.5540 | 4 |
| FKO | Catheter, Peritoneal Dialysis, Single Use | 第 2 类 | 21 CFR 876.5630 | 16 |
| FKP | System, Dialysate Delivery, Single Patient | 第 2 类 | 21 CFR 876.5820 | 50 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 第 2 类 | 21 CFR 876.5820 | 61 |
| FKR | Subsystem, Proportioning | 第 2 类 | 21 CFR 876.5820 | 12 |
| FKT | System, Dialysate Delivery, Sorbent Regenerated | 第 2 类 | 21 CFR 876.5600 | 19 |
| FKW | Tip, Vessel | 第 2 类 | 21 CFR 876.5540 | 3 |
| FKX | System, Peritoneal, Automatic Delivery | 第 2 类 | 21 CFR 876.5630 | 83 |
| FKY | Connector, Tubing, Dialysate | 第 2 类 | 21 CFR 876.5820 | 4 |
| FLA | Monitor, Temperature, Dialysis | 第 2 类 | 21 CFR 876.5820 | 3 |
| FLB | Meter, Conductivity, Induction, Remote Type | 第 2 类 | 21 CFR 876.5820 | 6 |
| FLC | Station, Dialysis Control, Negative Pressure Type | 第 2 类 | 21 CFR 876.5820 | 4 |
| FLD | Apparatus, Hemoperfusion, Sorbent | 第 2 类 | 21 CFR 876.5870 | 11 |
| FOC | Bag, Urine Collection, Newborn | 第 2 类 | 21 CFR 876.5250 | 4 |
| FON | Bag, Drainage, With Adhesive, Ostomy | 第 1 类 | 21 CFR 876.5900 | 3 |
| FPD | Tube, Feeding | 第 2 类 | 21 CFR 876.5980 | 59 |
| FRQ | Tube, Levine | 第 2 类 | 21 CFR 876.5980 | 3 |
| FTI | Lamp, Endoscope, Incandescent | 第 2 类 | 21 CFR 876.1500 | 2 |
| FTJ | Colonoscope, General & Plastic Surgery | 第 2 类 | 21 CFR 876.1500 | |
| FTO | Prosthesis, Testicle | 第 3 类 | 21 CFR 876.3750 | |
| FTQ | Prosthesis, Penis, Rigid Rod | 第 2 类 | 21 CFR 876.3630 | 2 |
| GBL | Catheter, Ureteral, General & Plastic Surgery | 第 N 类 | 21 CFR 876.5130 | |
| GBM | Catheter, Urethral | 第 2 类 | 21 CFR 876.5130 | 71 |
| GBT | Catheter, Rectal | 第 2 类 | 21 CFR 876.5980 | 3 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation | 第 2 类 | 21 CFR 876.5010 | 26 |
| GCF | Proctoscope | 第 2 类 | 21 CFR 876.1500 | 2 |
| GCG | Peritoneoscope | 第 2 类 | 21 CFR 876.1500 | |
| GCH | Mediastinoscope, Diagnostic | 第 2 类 | 21 CFR 876.1500 | |
| GCI | Laryngoscope, Endoscope | 第 2 类 | 21 CFR 876.1500 | 14 |
| GCJ | Laparoscope, General & Plastic Surgery | 第 2 类 | 21 CFR 876.1500 | 1428 |
| GCK | Gastroscope, General & Plastic Surgery | 第 2 类 | 21 CFR 876.1500 | |
| GCL | Esophagoscope, General & Plastic Surgery | 第 2 类 | 21 CFR 876.1500 | 4 |
| GCM | Endoscope, Rigid | 第 2 类 | 21 CFR 876.1500 | 18 |
| GCN | Endoscope, Prism | 第 2 类 | 21 CFR 876.1500 | |
| GCO | Endoscope, Mirror | 第 2 类 | 21 CFR 876.1500 | 3 |
| GCP | Endoscope, Ac-Powered And Accessories | 第 2 类 | 21 CFR 876.1500 | 13 |
| GCQ | Endoscope, Flexible | 第 2 类 | 21 CFR 876.1500 | 5 |
| GCS | Endoscope, Battery-Powered And Accessories | 第 2 类 | 21 CFR 876.1500 | 9 |
| GCT | Light Source, Endoscope, Xenon Arc | 第 2 类 | 21 CFR 876.1500 | 47 |
| GCW | Transformer, Endoscope | 第 2 类 | 21 CFR 876.1500 | 1 |
| GDB | Endoscope, Fiber Optic | 第 2 类 | 21 CFR 876.1500 | 7 |
| GDS | Bag, Stomal | 第 1 类 | 21 CFR 876.5900 | 2 |
| JCW | Prosthesis, Penis, Inflatable | 第 3 类 | 21 CFR 876.3350 | |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 第 2 类 | 21 CFR 876.5980 | 23 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 第 2 类 | 21 CFR 876.5860 | 345 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 第 2 类 | 21 CFR 876.5630 | 113 |
| KDK | Container, Transport, Kidney | 第 2 类 | 21 CFR 876.5880 | 3 |
| KDL | Set, Perfusion, Kidney, Disposable | 第 2 类 | 21 CFR 876.5880 | 19 |
| KDM | Sigmoidoscope, Rigid, Non-Electrical | 第 2 类 | 21 CFR 876.1500 | 1 |
| KDN | System, Perfusion, Kidney | 第 2 类 | 21 CFR 876.5880 | 44 |
| KDO | Rongeur, Cystoscopic, Hot | 第 2 类 | 21 CFR 876.1500 | 1 |
| KGC | Tube, Gastro-Enterostomy | 第 2 类 | 21 CFR 876.5980 | 26 |
| KGD | Scissors For Cystoscope | 第 2 类 | 21 CFR 876.1500 | 2 |
| KGE | Forceps, Biopsy, Electric | 第 2 类 | 21 CFR 876.4300 | 46 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 第 2 类 | 21 CFR 876.1725 | 31 |
| KNQ | Dilator, Esophageal | 第 2 类 | 21 CFR 876.5365 | 40 |
| KNR | Adapter, A-V Shunt Or Fistula | 第 2 类 | 21 CFR 876.5540 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 第 2 类 | 21 CFR 876.4300 | 188 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 第 2 类 | 21 CFR 876.5980 | 651 |
| KNW | Instrument, Biopsy | 第 2 类 | 21 CFR 876.1075 | 365 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 第 2 类 | 21 CFR 876.5250 | 206 |
| KNY | Accessories, Catheter, G-U | 第 2 类 | 21 CFR 876.5130 | 65 |
| KNZ | Accessories, A-V Shunt | 第 2 类 | 21 CFR 876.5540 | 10 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 第 1 类 | 21 CFR 876.4730 | 44 |
| KOB | Catheter, Suprapubic (And Accessories) | 第 2 类 | 21 CFR 876.5090 | 32 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 第 2 类 | 21 CFR 876.5820 | 182 |
| KOD | Catheter, Urological | 第 2 类 | 21 CFR 876.5130 | 238 |
| KOE | Dilator, Urethral | 第 2 类 | 21 CFR 876.5520 | 27 |
| KPF | System, Dialysate Delivery, Semi-Automatic, Peritoneal | 第 2 类 | 21 CFR 876.5630 | 13 |
| KPH | Catheter, Rectal For Continent Ileostomy | 第 1 类 | 21 CFR 876.5030 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 第 2 类 | 21 CFR 876.5320 | 96 |
| KPL | Colonic Irrigation System | 第 2 类 | 21 CFR 876.5220 | 40 |
| KPM | Shunt, Peritoneal | 第 2 类 | 21 CFR 876.5955 | 19 |
| KPN | Alarm, Conditioned Response Enuresis | 第 2 类 | 21 CFR 876.2040 | 37 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 第 2 类 | 21 CFR 876.5820 | 124 |
| KPP | Peritoneal Dialysate Filter | 第 2 类 | 21 CFR 876.5630 | 3 |
| KQQ | Tubing, Dialysate (And Connector) | 第 2 类 | 21 CFR 876.5820 | 1 |
| KQR | Detector, Air Or Foam | 第 2 类 | 21 CFR 876.5820 | |
| KQS | Table, Cystometric, Non-Electric And Accessories | 第 1 类 | 21 CFR 876.4890 | 8 |
| KQT | Evacuator, Gastro-Urology | 第 2 类 | 21 CFR 876.4370 | 14 |
| KXM | System Accessories, Extracorporeal | 第 2 类 | 21 CFR 876.5820 | 4 |
| KYH | Endoscope, Ophthalmic | 第 2 类 | 21 CFR 876.1500 | 1 |
| LBW | Set, Dialysis, Single Needle (Co-Axial Flow) | 第 2 类 | 21 CFR 876.5540 | 5 |
| LCG | Intestinal Splinting Tubes | 第 2 类 | 21 CFR 876.5980 | |
| LEY | Set, Oral Administration | 第 2 类 | 21 CFR 876.5980 | 1 |
| LFJ | Catheter, Subclavian | 第 2 类 | 21 CFR 876.5540 | 65 |
| LFK | Catheter, Femoral | 第 2 类 | 21 CFR 876.5540 | 16 |
| LIF | Dialyzer Reprocessing System | 第 2 类 | 21 CFR 876.5820 | 57 |
| LJH | System, Irrigation, Urological | 第 2 类 | 21 CFR 876.5130 | 28 |
| LKY | Device, External Penile Rigidity | 第 2 类 | 21 CFR 876.5020 | 87 |
| LLB | System, Blood, Extracorporeal And Accessories | 第 2 类 | 21 CFR 876.5820 | 2 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 第 2 类 | 21 CFR 876.5990 | 56 |
| LQC | Lithotriptor, Biliary Mechanical | 第 2 类 | 21 CFR 876.4500 | 11 |
| LQR | Dislodger, Stone, Biliary | 第 2 类 | 21 CFR 876.5010 | 38 |
| LRI | Ph Meter For Dialysis Hydrogen Ion Concentration | 第 2 类 | 21 CFR 876.5820 | 1 |
| LYK | Angioscope | 第 2 类 | 21 CFR 876.1500 | 41 |
| MFJ | Device, Endoscopic Suturing | 第 2 类 | 21 CFR 876.1500 | 1 |
| MJC | Catheter, Urological (Antimicrobial) And Accessories | 第 2 类 | 21 CFR 876.5130 | 10 |
| MLW | Warmer, Peritoneal Dialysate | 第 2 类 | 21 CFR 876.5630 | 6 |
| MMZ | Table, Cystometric, Electric | 第 2 类 | 21 CFR 876.4890 | 4 |
| MND | Ligator, Esophageal | 第 2 类 | 21 CFR 876.4400 | 15 |
| MNG | External Urethral Occluder, Urinary Incontinence-Control, Female | 第 1 类 | 21 CFR 876.5160 | 7 |
| MNK | Endoscopic Bite Block | 第 1 类 | 21 CFR 876.1500 | 6 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | 第 1 类 | 21 CFR 876.1500 | 4 |
| MNV | Strip, Dialysate Ph Indicator | 第 2 类 | 21 CFR 876.5820 | 6 |
| MON | System, Hemodialysis, Remote Accessories | 第 1 类 | 21 CFR 876.5820 | |
| MPA | Endoilluminator | 第 2 类 | 21 CFR 876.1500 | 41 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 第 2 类 | 21 CFR 876.5540 | 38 |
| MQS | System, Hemodialysis, Access Recirculation Monitoring | 第 2 类 | 21 CFR 876.5820 | 18 |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | 第 2 类 | 21 CFR 876.5880 | 13 |
| MSD | Catheter, Hemodialysis, Implanted | 第 2 类 | 21 CFR 876.5540 | 124 |
| MSE | Hemodialyzer, Re-Use, Low Flux | 第 2 类 | 21 CFR 876.5820 | 7 |
| MSF | Hemodialyzer, Re-Use, High Flux | 第 2 类 | 21 CFR 876.5860 | 8 |
| MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | 第 2 类 | 21 CFR 876.5665 | 13 |
| MSZ | Strip, Test, Reagent, Residuals For Dialysate | 第 2 类 | 21 CFR 876.5665 | |
| MYE | System, Electrogastrography (Egg) | 第 2 类 | 21 CFR 876.1735 | 8 |
| NAM | Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence | 第 2 类 | 21 CFR 876.5310 | 8 |
| NAY | System, Surgical, Computer Controlled Instrument | 第 2 类 | 21 CFR 876.1500 | 165 |
| NBG | Marker, Colon | 第 2 类 | 21 CFR 876.1500 | 2 |
| NDS | Media, Culture, Ex Vivo, Tissue And Cell | 第 2 类 | 21 CFR 876.5885 | 9 |
| NEQ | Device, Telemedicine, Robotic | 第 2 类 | 21 CFR 876.1500 | 2 |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 第 2 类 | 21 CFR 876.1300 | 47 |
| NFK | Kit, Repair, Catheter, Hemodialysis | 第 2 类 | 21 CFR 876.5540 | 11 |
| NGU | Balloon, Liver Tamponade | 第 2 类 | 21 CFR 876.5980 | 1 |
| NHV | System, Water Purification, General Medical Use | 第 2 类 | 21 CFR 876.5665 | 11 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 第 2 类 | 21 CFR 876.5540 | 12 |
| NIF | Catheter, Hemodialysis, Triple Lumen, Implanted | 第 2 类 | 21 CFR 876.5540 | |
| NIH | Disinfectant, Subsystem, Water Purification | 第 2 类 | 21 CFR 876.5665 | 1 |
| NII | Disinfectant, Dialysate Delivery System | 第 2 类 | 21 CFR 876.5860 | 2 |
| NKZ | Endoilluminator, Reprocessed | 第 2 类 | 21 CFR 876.1500 | |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 第 2 类 | 21 CFR 876.1500 | 23 |
| NLR | Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Repro | 第 2 类 | 21 CFR 876.4300 | 1 |
| NLS | Instrument, Biopsy, Reprocessed | 第 2 类 | 21 CFR 876.1075 | |
| NLT | Snare, Flexible, Reprocessed | 第 2 类 | 21 CFR 876.4300 | |
| NLU | Forceps, Biopsy, Electric, Reprocessed | 第 2 类 | 21 CFR 876.4300 | 4 |
| NLV | Electrode, Flexible Suction Coagulator, Reprocessed | 第 2 类 | 21 CFR 876.4300 | |
| NLW | Electrode, Electrosurgical, Active, Urological, Reprocessed | 第 2 类 | 21 CFR 876.4300 | 1 |
| NLX | Needle, Pneumoperitoneum, Spring Loaded, Reprocessed | 第 2 类 | 21 CFR 876.1500 | |
| NML | Catheter, Biliary, Reprocessed | 第 2 类 | 21 CFR 876.5010 | 1 |
| NMX | Needle And Needle Set, Gastro-Urology, Reprocessed | 第 2 类 | 21 CFR 876.1075 | |
| NMY | Needle, Endoscopic, Reprocessed | 第 2 类 | 21 CFR 876.1500 | |
| NNE | Needle, Fistula, Reprocessed | 第 2 类 | 21 CFR 876.5540 | |
| NNG | Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed | 第 2 类 | 21 CFR 876.5820 | |
| NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile | 第 1 类 | 21 CFR 876.5250 | |
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile | 第 1 类 | 21 CFR 876.5250 | |
| NNY | Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile | 第 1 类 | 21 CFR 876.5250 | |
| NNZ | System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Steri | 第 1 类 | 21 CFR 876.5250 | |
| NOA | Device, Paste-On For Incontinence, Non-Sterile | 第 1 类 | 21 CFR 876.5250 | |
| NON | Forceps, Biopsy, Non-Electric, Reprocessed | 第 1 类 | 21 CFR 876.1075 | 3 |
| NOO | Clamp, Dialysis Arm | 第 1 类 | 21 CFR 876.5540 | |
| NOY | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | 第 2 类 | 21 CFR 876.5550 | 4 |
| NQJ | Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral | 第 2 类 | 21 CFR 876.5540 | 4 |
| NQT | Dislodger, Stone, Flexible, Ureteral, Reprocessed | 第 2 类 | 21 CFR 876.4680 | |
| NQU | Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed | 第 2 类 | 21 CFR 876.4680 | |
| NQV | Catheter, Suction, Tracheobronchial, Reprocessed | 第 1 类 | 21 CFR 876.4680 | |
| NSI | System, Imaging, Esophageal, Wireless, Capsule | 第 2 类 | 21 CFR 876.1300 | 7 |
| NTN | Led Light Source | 第 2 类 | 21 CFR 876.1500 | 9 |
| NTZ | Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator | 第 2 类 | 21 CFR 876.5820 | 1 |
| NUB | Colonic Irrigation System, General Well Being | 第 3 类 | 21 CFR 876.5220 | |
| NVE | Washer, Cleaner, Automated, Endoscope | 第 2 类 | 21 CFR 876.1500 | 12 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | 第 2 类 | 21 CFR 876.1500 | 9 |
| NWI | Electrosurgical Electrode Kit | 第 2 类 | 21 CFR 876.4300 | |