| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| BSS | Tube, Nasogastric | 第 2 类 | 21 CFR 876.5980 | 13 |
| EXA | Selector, Size, Ostomy | 第 1 类 | 21 CFR 876.5900 | 1 |
| EXB | Collector, Ostomy | 第 1 类 | 21 CFR 876.5900 | 102 |
| EXD | Irrigator, Ostomy | 第 2 类 | 21 CFR 876.5895 | 12 |
| EXE | Protector, Ostomy | 第 1 类 | 21 CFR 876.5900 | 3 |
| EXF | Bag, Bile Collecting | 第 2 类 | 21 CFR 876.5010 | 9 |
| EXG | Bag, Urine Collecting, Ureterostomy | 第 1 类 | 21 CFR 876.5900 | |
| EXH | Bag, Urinary, Ileostomy | 第 1 类 | 21 CFR 876.5900 | |
| EXI | Device, Paste-On For Incontinence, Sterile | 第 1 类 | 21 CFR 876.5250 | 7 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 第 1 类 | 21 CFR 876.5250 | 22 |
| EXM | Truss, Umbilical | 第 1 类 | 21 CFR 876.5970 | |
| EXN | Support, Hernia | 第 1 类 | 21 CFR 876.5970 | 1 |
| EXQ | Cystometer, Electrical Recording | 第 2 类 | 21 CFR 876.1620 | 8 |
| EXR | Urinometer, Mechanical | 第 2 类 | 21 CFR 876.1800 | 9 |
| EXS | Urinometer, Electrical | 第 2 类 | 21 CFR 876.1800 | |
| EXW | Pill, Radio | 第 2 类 | 21 CFR 876.1725 | 1 |
| EXX | Probe, Rectal, Non-Powered | 第 1 类 | 21 CFR 876.4730 | |
| EXY | Uroflowmeter | 第 2 类 | 21 CFR 876.1800 | 16 |
| EXZ | Equipment, Photographic, For Physiologic Function Monitor | 第 1 类 | 21 CFR 876.1500 | |
| EYA | Stylet, Ureteral | 第 1 类 | 21 CFR 876.5130 | |
| EYB | Catheter, Ureteral, Gastro-Urology | 第 2 类 | 21 CFR 876.5130 | 28 |
| EYC | Catheter, Upper Urinary Tract | 第 2 类 | 21 CFR 876.5130 | 5 |
| EYD | Stirrups | 第 1 类 | 21 CFR 876.4890 | |
| EYH | Table, Cysto, Non-Electrical | 第 1 类 | 21 CFR 876.4890 | |
| EYI | Adaptor, Ureteral Catheter | 第 1 类 | 21 CFR 876.5130 | |
| EYJ | Holder, Ureteral Catheter | 第 1 类 | 21 CFR 876.5130 | |
| EYK | Connector, Ureteral Catheter | 第 1 类 | 21 CFR 876.5130 | 1 |
| EYN | Tray, Irrigation, Sterile | 第 2 类 | 21 CFR 876.5980 | 15 |
| EYQ | Garment, Protective, For Incontinence | 第 1 类 | 21 CFR 876.5920 | 56 |
| EYS | Ribdam | 第 1 类 | 21 CFR 876.4560 | |
| EYT | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile | 第 1 类 | 21 CFR 876.5250 | 4 |
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | 第 1 类 | 21 CFR 876.5250 | 14 |
| EZB | Stylet For Catheter, Gastro-Urology | 第 1 类 | 21 CFR 876.5130 | 3 |
| EZC | Catheter, Coude | 第 2 类 | 21 CFR 876.5130 | 7 |
| EZD | Catheter, Straight | 第 2 类 | 21 CFR 876.5130 | 86 |
| EZK | Catheter, Retention Type | 第 2 类 | 21 CFR 876.5980 | 3 |
| EZL | Catheter, Retention Type, Balloon | 第 2 类 | 21 CFR 876.5130 | 129 |
| EZM | Dilator, Esophageal (Metal Olive) Gastro-Urology | 第 2 类 | 21 CFR 876.5365 | |
| EZN | Dilator, Catheter, Ureteral | 第 2 类 | 21 CFR 876.5470 | 56 |
| EZO | Urethrotome | 第 2 类 | 21 CFR 876.4770 | 5 |
| EZP | Rod, Colostomy | 第 2 类 | 21 CFR 876.4270 | 2 |
| EZQ | Pouch, Colostomy | 第 1 类 | 21 CFR 876.5900 | 6 |
| EZR | Cement, Stomal Appliance, Ostomy | 第 1 类 | 21 CFR 876.5900 | 6 |
| EZS | Appliance, Colostomy, Disposable | 第 1 类 | 21 CFR 876.5900 | 1 |
| EZT | Pacemaker, Bladder | 第 3 类 | 21 CFR 876.5270 | |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | 第 3 类 | 21 CFR 876.5270 | |
| EZY | Device, Incontinence, Mechanical/Hydraulic | 第 3 类 | 21 CFR 876.5280 | |
| FAD | Stent, Ureteral | 第 2 类 | 21 CFR 876.4620 | 122 |
| FAE | Prosthesis, Penile | 第 2 类 | 21 CFR 876.3630 | 32 |
| FAF | Prosthesis, Testicular | 第 3 类 | 21 CFR 876.3750 | |
| FAH | Dilator, Urethral, Mechanical | 第 2 类 | 21 CFR 876.5520 | 4 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 第 2 类 | 21 CFR 876.1500 | 92 |
| FAK | Panendoscope (Gastroduodenoscope) | 第 2 类 | 21 CFR 876.1500 | 2 |
| FAL | Panendoscope (Urethroscope) | 第 2 类 | 21 CFR 876.1500 | 1 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 第 2 类 | 21 CFR 876.1500 | 24 |
| FAN | Sigmoidoscope, Rigid, Electrical | 第 2 类 | 21 CFR 876.1500 | 2 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 第 2 类 | 21 CFR 876.1620 | 85 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 第 1 类 | 21 CFR 876.5250 | 18 |
| FAR | Unit, Electrosurgical | 第 2 类 | 21 CFR 876.4300 | |
| FAS | Electrode, Electrosurgical, Active, Urological | 第 2 类 | 21 CFR 876.4300 | 58 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 第 2 类 | 21 CFR 876.5365 | 8 |
| FAX | Bougie, Urological | 第 1 类 | 21 CFR 876.5520 | 2 |
| FBI | Rongeur, Cystoscopic | 第 2 类 | 21 CFR 876.1500 | |
| FBJ | Cord, Electric For Transurethral Surgical Instrument | 第 2 类 | 21 CFR 876.4300 | |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 第 2 类 | 21 CFR 876.1500 | 89 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | 第 1 类 | 21 CFR 876.5090 | 9 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 第 2 类 | 21 CFR 876.1500 | 43 |
| FBO | Cystourethroscope | 第 2 类 | 21 CFR 876.1500 | 19 |
| FBP | Telescope, Rigid, Endoscopic | 第 2 类 | 21 CFR 876.1500 | 5 |
| FBQ | Trocar, Gastro-Urology | 第 2 类 | 21 CFR 876.5090 | 9 |
| FBR | Urethrometer | 第 1 类 | 21 CFR 876.5520 | |
| FBS | Sound, Metal, Interconnected | 第 1 类 | 21 CFR 876.4590 | 1 |
| FBW | Filiform And Filiform Follower | 第 1 类 | 21 CFR 876.5520 | 1 |
| FBX | Sound, Urethral, Metal Or Plastic | 第 1 类 | 21 CFR 876.5520 | 1 |
| FCB | Bag, Hemostatic | 第 2 类 | 21 CFR 876.5980 | |
| FCC | Endoscopic Magnetic Retriever | 第 2 类 | 21 CFR 876.1500 | 3 |
| FCD | Barium Enema Kit | 第 1 类 | 21 CFR 876.5210 | 2 |
| FCE | Enema Kit | 第 1 类 | 21 CFR 876.5210 | 30 |
| FCF | Instrument, Biopsy, Mechanical, Gastrointestinal | 第 2 类 | 21 CFR 876.1075 | 6 |
| FCG | Biopsy Needle | 第 2 类 | 21 CFR 876.1075 | 133 |
| FCH | Tray, Biopsy, Without Biopsy Instruments | 第 1 类 | 21 CFR 876.4730 | 2 |
| FCI | Punch, Biopsy | 第 2 类 | 21 CFR 876.1075 | 5 |
| FCK | Instrument, Biopsy, Suction | 第 2 类 | 21 CFR 876.1075 | 13 |
| FCL | Forceps, Biopsy, Non-Electric | 第 1 类 | 21 CFR 876.1075 | 39 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit | 第 2 类 | 21 CFR 876.5130 | 60 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | 第 2 类 | 21 CFR 876.5250 | 10 |
| FCO | Box, Battery, Rechargeable | 第 1 类 | 21 CFR 876.1500 | 20 |
| FCP | Box, Battery, Pocket | 第 1 类 | 21 CFR 876.1500 | 2 |
| FCQ | Light Source, Incandescent, Diagnostic | 第 2 类 | 21 CFR 876.1500 | 1 |
| FCR | Light Source, Photographic, Fiberoptic | 第 2 类 | 21 CFR 876.1500 | 3 |
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | 第 2 类 | 21 CFR 876.4020 | 10 |
| FCW | Light Source, Fiberoptic, Routine | 第 2 类 | 21 CFR 876.1500 | 31 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 第 2 类 | 21 CFR 876.1500 | 25 |
| FCY | Bulb, Inflation, For Endoscope | 第 1 类 | 21 CFR 876.1500 | 3 |
| FCZ | Tube, Smoke Removal, Endoscopic | 第 1 类 | 21 CFR 876.1500 | |
| FDA | Enteroscope And Accessories | 第 2 类 | 21 CFR 876.1500 | 20 |
| FDB | Plate, Patient | 第 2 类 | 21 CFR 876.4300 | |
| FDC | Resectoscope, Working Element | 第 2 类 | 21 CFR 876.1500 | 11 |
| FDE | Laparoscopy Kit | 第 2 类 | 21 CFR 876.1500 | 4 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 第 2 类 | 21 CFR 876.1500 | 114 |
| FDG | Retractor, Fiberoptic | 第 1 类 | 21 CFR 876.4530 | 2 |
| FDI | Snare, Flexible | 第 2 类 | 21 CFR 876.4300 | 63 |
| FDJ | Snare, Rigid Self-Opening | 第 2 类 | 21 CFR 876.4300 | |
| FDL | Wristlet, Patient Return | 第 2 类 | 21 CFR 876.4300 | |
| FDP | Apparatus, Pneumoperitoneum, Automatic | 第 2 类 | 21 CFR 876.1500 | 1 |
| FDR | Sphyncteroscope | 第 2 类 | 21 CFR 876.1500 | |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 第 2 类 | 21 CFR 876.1500 | 78 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 第 2 类 | 21 CFR 876.1500 | 35 |
| FDW | Esophagoscope, Rigid, Gastro-Urology | 第 2 类 | 21 CFR 876.1500 | |
| FDX | Endoscopic Cytology Brush | 第 2 类 | 21 CFR 876.1500 | 44 |
| FDY | Device, Measuring, For Panendoscope | 第 1 类 | 21 CFR 876.1500 | |
| FDZ | Attachment, Eyepiece, For Insertion Of Prescription Lens | 第 1 类 | 21 CFR 876.1500 | 2 |
| FEA | Attachment, Teaching, For Endoscope | 第 1 类 | 21 CFR 876.1500 | 2 |
| FEB | Accessories, Cleaning, For Endoscope | 第 2 类 | 21 CFR 876.1500 | 57 |
| FEC | Obturator, For Endoscope | 第 2 类 | 21 CFR 876.1500 | 3 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 第 2 类 | 21 CFR 876.1500 | 102 |
| FEF | Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation | 第 2 类 | 21 CFR 876.5980 | 1 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | 第 2 类 | 21 CFR 876.5980 | 13 |
| FEH | Electrode, Flexible Suction Coagulator | 第 2 类 | 21 CFR 876.4300 | 3 |
| FEI | Instrument, Special Lens, For Endoscope | 第 1 类 | 21 CFR 876.1500 | 2 |
| FEJ | Attachment, Binocular, For Endoscope | 第 1 类 | 21 CFR 876.1500 | 1 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | 第 1 类 | 21 CFR 876.1500 | 4 |
| FEN | Device, Cystometric, Hydraulic | 第 2 类 | 21 CFR 876.1620 | 36 |
| FEO | Lithotriptor, Ultrasonic | 第 2 类 | 21 CFR 876.4480 | 14 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | 第 2 类 | 21 CFR 876.1500 | 21 |
| FER | Anoscope And Accessories | 第 2 类 | 21 CFR 876.1500 | 27 |
| FES | Recorder, External, Pressure, Amplifier & Transducer | 第 2 类 | 21 CFR 876.1725 | 2 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 第 2 类 | 21 CFR 876.1500 | 100 |
| FEW | Catheter, Malecot | 第 2 类 | 21 CFR 876.5090 | 6 |
| FEX | Instrument, Catheter, Punch | 第 1 类 | 21 CFR 876.5090 | 2 |
| FEZ | Catheter And Tube, Suprapubic | 第 2 类 | 21 CFR 876.5090 | 1 |
| FFA | Tube, Drainage, Suprapubic | 第 2 类 | 21 CFR 876.5090 | 3 |
| FFD | Evacuator, Bladder, Manually Operated | 第 1 类 | 21 CFR 876.4370 | 2 |
| FFE | System, Water Jet Catheter, Renal | 第 2 类 | 21 CFR 876.4650 | 1 |
| FFF | Cover, Biopsy Forceps | 第 1 类 | 21 CFR 876.1075 | 1 |
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | 第 2 类 | 21 CFR 876.1800 | 17 |
| FFH | Collector, Urine, Pediatric, For Indwelling Catheter | 第 2 类 | 21 CFR 876.5250 | 3 |
| FFI | System, Alarm, Electrosurgical | 第 2 类 | 21 CFR 876.4300 | 1 |
| FFK | Lithotriptor, Electro-Hydraulic | 第 2 类 | 21 CFR 876.4480 | 61 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 第 2 类 | 21 CFR 876.4680 | 52 |
| FFN | Clamp, Non-Electrical | 第 1 类 | 21 CFR 876.4730 | 5 |
| FFO | Retractor, Self-Retaining | 第 1 类 | 21 CFR 876.4730 | 5 |
| FFP | Dilator, Rectal | 第 1 类 | 21 CFR 876.5450 | 5 |
| FFQ | Speculum, Rectal | 第 1 类 | 21 CFR 876.4730 | 1 |
| FFR | Device, Locking, For Intestinal Clamp | 第 1 类 | 21 CFR 876.4730 | |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 第 2 类 | 21 CFR 876.1500 | 26 |
| FFT | Electrode, Ph, Stomach | 第 1 类 | 21 CFR 876.1400 | 49 |
| FFW | String And Tubes, Gastrointestinal, To Locate Internal Bleeding | 第 2 类 | 21 CFR 876.5980 | |
| FFX | System, Gastrointestinal Motility (Electrical) | 第 2 类 | 21 CFR 876.1725 | 69 |
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | 第 1 类 | 21 CFR 876.1500 | 2 |
| FFZ | Cord, Electric, For Endoscope | 第 2 类 | 21 CFR 876.1500 | 3 |
| FGA | Kit, Nephroscope | 第 2 类 | 21 CFR 876.1500 | 10 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 第 2 类 | 21 CFR 876.1500 | 117 |
| FGC | Urethroscope | 第 2 类 | 21 CFR 876.1500 | 3 |
| FGD | Catheter, Retention, Barium Enema With Bag | 第 2 类 | 21 CFR 876.5980 | 6 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 第 2 类 | 21 CFR 876.5010 | 476 |
| FGF | Catheter, Ureteral Disposable (X-Ray) | 第 2 类 | 21 CFR 876.5130 | 1 |
| FGH | Catheter, Double Lumen Female Urethrographic | 第 2 类 | 21 CFR 876.5130 | 1 |
| FGI | Catheter, Urethrographic, Male | 第 2 类 | 21 CFR 876.5130 | 3 |
| FGK | Tripsor, Stone, Bladder | 第 2 类 | 21 CFR 876.4500 | 1 |
| FGM | Probe And Director, Gastro-Urology | 第 1 类 | 21 CFR 876.4730 | 7 |
| FGN | Retractor, Non-Self-Retaining | 第 1 类 | 21 CFR 876.4730 | |
| FGO | Dislodger, Stone, Flexible | 第 2 类 | 21 CFR 876.4680 | 19 |
| FGS | Carrier, Sponge, Endoscopic | 第 2 类 | 21 CFR 876.1500 | 4 |
| FGW | Clamp, Electrical | 第 2 类 | 21 CFR 876.4300 | |
| FGX | Snare, Non-Electrical | 第 1 类 | 21 CFR 876.4730 | |
| FHA | Clamp, Penile | 第 1 类 | 21 CFR 876.5160 | 11 |
| FHB | Hook, Gastro-Urology | 第 1 类 | 21 CFR 876.4730 | |
| FHC | Adaptor To The Cord, For Transurethral Surgical Instrument | 第 2 类 | 21 CFR 876.4300 | |
| FHF | System, Evacuator, Fluid | 第 2 类 | 21 CFR 876.4370 | 3 |
| FHH | Crusher, Spur, Colostomy | 第 1 类 | 21 CFR 876.4730 | |
| FHI | Ring, Laparotomy | 第 1 类 | 21 CFR 876.4730 | |
| FHK | Spreader, Bladder Neck | 第 1 类 | 21 CFR 876.4730 | |
| FHL | Scoop | 第 1 类 | 21 CFR 876.4730 | |
| FHN | Ligator, Hemorrhoidal | 第 2 类 | 21 CFR 876.4400 | 22 |
| FHO | Pneumoperitoneum Needle | 第 2 类 | 21 CFR 876.1500 | 15 |
| FHP | Needle, Pneumoperitoneum, Simple | 第 2 类 | 21 CFR 876.1500 | 2 |
| FHQ | Holder, Needle, Gastroenterologic | 第 1 类 | 21 CFR 876.4730 | 7 |
| FHS | Dialyzer, Single Coil | 第 2 类 | 21 CFR 876.5820 | 12 |
| FHT | Set, Gavage, Infant, Sterile | 第 2 类 | 21 CFR 876.5980 | 1 |
| FHW | Device, Impotence, Mechanical/Hydraulic | 第 3 类 | 21 CFR 876.3350 | |
| FHX | Jelly, Lubricating, For Transurethral Surgical Instrument | 第 2 类 | 21 CFR 876.1500 | 6 |
| FHY | Jelly, Contact, For Transurethral Surgical Instrument | 第 2 类 | 21 CFR 876.4300 | |
| FHZ | Desiccator, Transurethral | 第 2 类 | 21 CFR 876.4300 | |
| FIA | Chair, Dialysis, Unpowered, Without Scales | 第 1 类 | 21 CFR 876.5820 | |
| FIB | Protector, Transducer, Dialysis | 第 2 类 | 21 CFR 876.5820 | 35 |
| FID | Tubing, Dialysate | 第 2 类 | 21 CFR 876.5820 | 3 |
| FIE | Needle, Fistula | 第 2 类 | 21 CFR 876.5540 | 80 |
| FIF | Set, Dialysis, Single Needle With Uni-Directional Pump | 第 2 类 | 21 CFR 876.5820 | 6 |
| FIG | Clamp, Tubing, Blood, Automatic | 第 2 类 | 21 CFR 876.5820 | 4 |
| FIH | Pump, Infusion Or Syringe, Extra-Luminal | 第 2 类 | 21 CFR 876.5820 | 5 |
| FII | System, Dialysate Delivery, Sealed | 第 2 类 | 21 CFR 876.5860 | 5 |
| FIJ | System, Dialysate Delivery, Recirculating, Single Pass | 第 2 类 | 21 CFR 876.5820 | 1 |
| FIK | System, Dialysate Delivery, Recirculating | 第 2 类 | 21 CFR 876.5820 | |
| FIL | System, Dialysate Delivery, Single Pass | 第 2 类 | 21 CFR 876.5820 | 8 |
| FIN | Tank, Holding, Dialysis | 第 2 类 | 21 CFR 876.5820 | 18 |
| FIP | Subsystem, Water Purification | 第 2 类 | 21 CFR 876.5665 | 117 |
| FIQ | Cannula, A-V Shunt | 第 2 类 | 21 CFR 876.5540 | 23 |
| FIR | Pump, Blood, Extra-Luminal | 第 2 类 | 21 CFR 876.5820 | 7 |
| FIS | Flowmeter, Dialysate | 第 2 类 | 21 CFR 876.5820 | |