| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 第 2 类 | 21 CFR 878.4780 | 159 |
| BTX | Board, Arm (With Cover), Sterile | 第 1 类 | 21 CFR 878.3910 | 13 |
| BWA | Unit, Electrosurgical And Coagulation, With Accessories | 第 2 类 | 21 CFR 878.4400 | 3 |
| BWN | Table And Attachments, Operating-Room | 第 1 类 | 21 CFR 878.4950 | 20 |
| BWP | Shoe And Shoe Cover, Conductive | 第 1 类 | 21 CFR 878.4040 | 3 |
| DWG | Electrosurgical Device | 第 2 类 | 21 CFR 878.4400 | 4 |
| DWH | Blade, Saw, Surgical, Cardiovascular | 第 1 类 | 21 CFR 878.4820 | 4 |
| DWI | Saw, Electrically Powered | 第 1 类 | 21 CFR 878.4820 | 2 |
| DWO | Needle, Biopsy, Cardiovascular | 第 1 类 | 21 CFR 878.4800 | 11 |
| EMF | Knife, Surgical | 第 1 类 | 21 CFR 878.4800 | 21 |
| EPT | Microscope, Surgical | 第 1 类 | 21 CFR 878.4700 | 18 |
| EPW | Support, Head, Surgical, Ent | 第 1 类 | 21 CFR 878.4950 | 2 |
| EPY | Speculum, Ent | 第 1 类 | 21 CFR 878.1800 | 12 |
| ERY | Drape, Surgical, Ent | 第 2 类 | 21 CFR 878.4370 | |
| ESF | Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent | 第 2 类 | 21 CFR 878.3500 | 2 |
| ESW | Prosthesis, Esophageal | 第 2 类 | 21 CFR 878.3610 | 60 |
| EYF | Protector, Wound, Plastic | 第 1 类 | 21 CFR 878.4014 | 5 |
| EYR | Tourniquet, Gastro-Urology | 第 1 类 | 21 CFR 878.5900 | 2 |
| EYX | Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | 第 2 类 | 21 CFR 878.4370 | 1 |
| EYY | Drape, Urological, Disposable | 第 2 类 | 21 CFR 878.4370 | 2 |
| EZX | Mesh, Surgical, Metal | 第 2 类 | 21 CFR 878.3300 | 12 |
| FAZ | System, Cryosurgical, Liquid Nitrogen, For Urology | 第 2 类 | 21 CFR 878.4350 | |
| FGY | Cannula, Injection | 第 1 类 | 21 CFR 878.4200 | 2 |
| FHM | Apparatus, Suturing, Stomach And Intestinal | 第 1 类 | 21 CFR 878.4800 | 2 |
| FHR | Needle, Gastro-Urology | 第 1 类 | 21 CFR 878.4800 | 1 |
| FLJ | Unit, Airflow, Laminar | 第 2 类 | 21 CFR 878.5070 | |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention | 第 2 类 | 21 CFR 878.4850 | 110 |
| FNW | Pad, Kelly | 第 2 类 | 21 CFR 878.4370 | 2 |
| FQO | Table, Operating-Room, Ac-Powered | 第 1 类 | 21 CFR 878.4960 | 35 |
| FQP | Lamp, Operating-Room | 第 2 类 | 21 CFR 878.4580 | 5 |
| FRT | Unit, Isolation, Surgical | 第 2 类 | 21 CFR 878.5070 | |
| FSE | Table, Operating-Room, Manual | 第 1 类 | 21 CFR 878.4950 | 13 |
| FSH | Tray, Surgical, Needle | 第 1 类 | 21 CFR 878.4800 | 8 |
| FSM | Tray, Surgical, Instrument | 第 1 类 | 21 CFR 878.4800 | 76 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4700 | 15 |
| FSP | Loupe, Diagnostic/Surgical | 第 1 类 | 21 CFR 878.4800 | 4 |
| FSQ | Light, Surgical, Instrument | 第 2 类 | 21 CFR 878.4580 | 7 |
| FSS | Light, Surgical, Floor Standing | 第 2 类 | 21 CFR 878.4580 | 20 |
| FST | Light, Surgical, Fiberoptic | 第 2 类 | 21 CFR 878.4580 | 45 |
| FSW | Light, Surgical, Endoscopic | 第 2 类 | 21 CFR 878.4580 | 8 |
| FSX | Light, Surgical, Connector | 第 2 类 | 21 CFR 878.4580 | |
| FSY | Light, Surgical, Ceiling Mounted | 第 2 类 | 21 CFR 878.4580 | 74 |
| FSZ | Light, Surgical, Carrier | 第 2 类 | 21 CFR 878.4580 | |
| FTA | Light, Surgical, Accessories | 第 2 类 | 21 CFR 878.4580 | 26 |
| FTC | Light, Ultraviolet, Dermatological | 第 2 类 | 21 CFR 878.4630 | 272 |
| FTD | Lamp, Surgical | 第 2 类 | 21 CFR 878.4580 | 29 |
| FTF | Illuminator, Non-Remote | 第 2 类 | 21 CFR 878.4580 | 4 |
| FTG | Illuminator, Remote | 第 2 类 | 21 CFR 878.4580 | 2 |
| FTH | Camera, Still, Microsurgical | 第 1 类 | 21 CFR 878.4160 | |
| FTL | Mesh, Surgical, Polymeric | 第 2 类 | 21 CFR 878.3300 | 336 |
| FTM | Mesh, Surgical | 第 2 类 | 21 CFR 878.3300 | 164 |
| FTN | Plastic Surgery And Accessories Kit | 第 1 类 | 21 CFR 878.3925 | |
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | 第 3 类 | 21 CFR 878.3540 | |
| FTS | Camera, Cine, Endoscopic, With Audio | 第 1 类 | 21 CFR 878.4160 | 2 |
| FTT | Camera, Still, Surgical | 第 1 类 | 21 CFR 878.4160 | 1 |
| FTX | Mirror, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 1 |
| FTY | Tape, Measuring, Rulers And Calipers | 第 1 类 | 21 CFR 878.4800 | 23 |
| FWB | Camera, Television, Surgical, Without Audio | 第 1 类 | 21 CFR 878.4160 | 6 |
| FWC | Camera, Television, Surgical, With Audio | 第 1 类 | 21 CFR 878.4160 | 3 |
| FWD | Camera, Television, Microsurgical, Without Audio | 第 1 类 | 21 CFR 878.4160 | 5 |
| FWE | Camera, Television, Microsurgical, With Audio | 第 1 类 | 21 CFR 878.4160 | |
| FWF | Camera, Television, Endoscopic, Without Audio | 第 1 类 | 21 CFR 878.4160 | 23 |
| FWG | Camera, Television, Endoscopic, With Audio | 第 1 类 | 21 CFR 878.4160 | 2 |
| FWH | Camera, Cine, Surgical, Without Audio | 第 1 类 | 21 CFR 878.4160 | 2 |
| FWI | Camera, Cine, Surgical, With Audio | 第 1 类 | 21 CFR 878.4160 | |
| FWJ | Camera, Cine, Microsurgical, Without Audio | 第 1 类 | 21 CFR 878.4160 | |
| FWK | Camera, Cine, Microsurgical, With Audio | 第 1 类 | 21 CFR 878.4160 | |
| FWL | Camera, Cine, Endoscopic, Without Audio | 第 1 类 | 21 CFR 878.4160 | 2 |
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | 第 3 类 | 21 CFR 878.3530 | |
| FWP | Prosthesis, Chin, Internal | 第 2 类 | 21 CFR 878.3550 | 66 |
| FWW | Table, Operating-Room, Pneumatic | 第 1 类 | 21 CFR 878.4960 | 6 |
| FWX | Table, Operating-Room, Mechanical | 第 1 类 | 21 CFR 878.4950 | 3 |
| FWY | Table, Operating-Room, Non-Electrical | 第 1 类 | 21 CFR 878.4950 | 4 |
| FWZ | Operating Room Accessories Table Tray | 第 1 类 | 21 CFR 878.4950 | 61 |
| FXE | Speculum, Non-Illuminated | 第 1 类 | 21 CFR 878.1800 | |
| FXF | Speculum, Illuminated | 第 1 类 | 21 CFR 878.1800 | 1 |
| FXG | Specula Accessories | 第 1 类 | 21 CFR 878.1800 | 1 |
| FXM | Camera, Still, Endoscopic | 第 1 类 | 21 CFR 878.4160 | 1 |
| FXN | Tape, Camera, Surgical | 第 1 类 | 21 CFR 878.4160 | 4 |
| FXO | Suit, Surgical | 第 1 类 | 21 CFR 878.4040 | 6 |
| FXP | Cover, Shoe, Operating-Room | 第 1 类 | 21 CFR 878.4040 | 36 |
| FXQ | Lens, Camera, Surgical | 第 1 类 | 21 CFR 878.4160 | 1 |
| FXR | Holder, Camera, Surgical | 第 1 类 | 21 CFR 878.4160 | 2 |
| FXS | Frame, Camera, Surgical | 第 1 类 | 21 CFR 878.4160 | |
| FXT | Film, Camera, Surgical | 第 1 类 | 21 CFR 878.4160 | |
| FXW | Shoes, Operating-Room | 第 1 类 | 21 CFR 878.4040 | 1 |
| FXX | Mask, Surgical | 第 2 类 | 21 CFR 878.4040 | 607 |
| FXY | Hood, Surgical | 第 2 类 | 21 CFR 878.4040 | 13 |
| FXZ | Helmet, Surgical | 第 1 类 | 21 CFR 878.4040 | |
| FYA | Gown, Surgical | 第 2 类 | 21 CFR 878.4040 | 298 |
| FYB | Gown, Patient | 第 2 类 | 21 CFR 878.4040 | 6 |
| FYC | Gown, Isolation, Surgical | 第 2 类 | 21 CFR 878.4040 | 68 |
| FYD | Apparatus, Exhaust, Surgical | 第 2 类 | 21 CFR 878.5070 | 75 |
| FYE | Dress, Surgical | 第 1 类 | 21 CFR 878.4040 | 7 |
| FYF | Cap, Surgical | 第 1 类 | 21 CFR 878.4040 | 32 |
| FYH | Splint, Extremity, Noninflatable, External, Sterile | 第 1 类 | 21 CFR 878.3910 | 8 |
| FYI | Appliance, Facial Fracture, External | 第 1 类 | 21 CFR 878.3250 | 4 |
| FZD | Prosthesis, Ear, Internal | 第 2 类 | 21 CFR 878.3590 | 3 |
| FZE | Prosthesis, Nose, Internal | 第 2 类 | 21 CFR 878.3680 | 42 |
| FZF | Splint, Extremity, Inflatable, External | 第 1 类 | 21 CFR 878.3900 | 7 |
| FZG | Apparatus, Air Handling, Bench | 第 2 类 | 21 CFR 878.5070 | 1 |
| FZH | Apparatus, Air Handling, Room | 第 2 类 | 21 CFR 878.5070 | 4 |
| FZI | Apparatus, Air Handling, Enclosure | 第 2 类 | 21 CFR 878.5070 | 5 |
| FZK | Chair, Surgical, Non-Electrical | 第 1 类 | 21 CFR 878.4950 | 2 |
| FZM | Stool, Operating-Room | 第 1 类 | 21 CFR 878.4950 | 1 |
| FZO | Chisel, Surgical, Manual | 第 1 类 | 21 CFR 878.4800 | 2 |
| FZP | Clip, Implantable | 第 2 类 | 21 CFR 878.4300 | 177 |
| FZQ | Clip, Removable (Skin) | 第 1 类 | 21 CFR 878.4320 | 6 |
| FZR | Contractor, Surgical | 第 1 类 | 21 CFR 878.4800 | |
| FZS | Curette, Surgical, General Use | 第 1 类 | 21 CFR 878.4800 | 14 |
| FZT | Cutter, Surgical | 第 1 类 | 21 CFR 878.4800 | 52 |
| FZW | Expander, Surgical, Skin Graft | 第 1 类 | 21 CFR 878.4800 | 8 |
| FZX | Guide, Surgical, Instrument | 第 1 类 | 21 CFR 878.4800 | 19 |
| FZY | Hammer, Surgical | 第 1 类 | 21 CFR 878.4800 | 1 |
| FZZ | Marker, Skin | 第 1 类 | 21 CFR 878.4660 | 23 |
| GAA | Needle, Aspiration And Injection, Disposable | 第 1 类 | 21 CFR 878.4800 | 107 |
| GAB | Needle, Suturing, Disposable | 第 1 类 | 21 CFR 878.4800 | 8 |
| GAC | Rasp, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 2 |
| GAD | Retractor | 第 1 类 | 21 CFR 878.4800 | 100 |
| GAE | Snare, Surgical | 第 1 类 | 21 CFR 878.4800 | 4 |
| GAF | Spatula, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 5 |
| GAH | Stylet, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 7 |
| GAI | Stripper, Vein, Reusable | 第 1 类 | 21 CFR 878.4800 | |
| GAJ | Stripper, Vein, Disposable | 第 1 类 | 21 CFR 878.4800 | |
| GAK | Suture, Absorbable | 第 2 类 | 21 CFR 878.4830 | 1 |
| GAL | Suture, Absorbable, Natural | 第 2 类 | 21 CFR 878.4830 | 30 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 第 2 类 | 21 CFR 878.4493 | 149 |
| GAN | Suture, Absorbable, Synthetic | 第 2 类 | 21 CFR 878.4830 | 7 |
| GAO | Suture, Nonabsorbable | 第 2 类 | 21 CFR 878.4495 | 4 |
| GAP | Suture, Nonabsorbable, Silk | 第 2 类 | 21 CFR 878.5030 | 41 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 第 2 类 | 21 CFR 878.4495 | 32 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 第 2 类 | 21 CFR 878.5020 | 57 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 第 2 类 | 21 CFR 878.5000 | 17 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 第 2 类 | 21 CFR 878.5000 | 176 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 第 2 类 | 21 CFR 878.5010 | 85 |
| GAX | Tourniquet, Nonpneumatic | 第 1 类 | 21 CFR 878.5900 | 20 |
| GBA | Catheter, Balloon Type | 第 1 类 | 21 CFR 878.4200 | 5 |
| GBB | Chair, Surgical, Ac-Powered | 第 1 类 | 21 CFR 878.4960 | 8 |
| GBC | Lamp, Surgical, Incandescent | 第 2 类 | 21 CFR 878.4580 | 4 |
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | 第 1 类 | 21 CFR 878.3800 | 17 |
| GBJ | Prosthesis, Adhesive, External | 第 1 类 | 21 CFR 878.3750 | 4 |
| GBN | Catheter, Pediatric, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4200 | 2 |
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4200 | 11 |
| GBP | Catheter, Multiple Lumen | 第 1 类 | 21 CFR 878.4200 | 3 |
| GBQ | Catheter, Continuous Irrigation | 第 1 类 | 21 CFR 878.4200 | 8 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4200 | 27 |
| GBW | Catheter, Peritoneal | 第 1 类 | 21 CFR 878.4200 | 17 |
| GBX | Catheter, Irrigation | 第 1 类 | 21 CFR 878.4200 | 77 |
| GBY | Catheter, Eustachian, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4200 | |
| GBZ | Catheter, Cholangiography | 第 1 类 | 21 CFR 878.4200 | 24 |
| GCB | Needle, Catheter | 第 1 类 | 21 CFR 878.4200 | 8 |
| GCC | Dilator, Catheter | 第 1 类 | 21 CFR 878.4200 | 5 |
| GCD | Connector, Catheter | 第 1 类 | 21 CFR 878.4200 | 8 |
| GCE | Adaptor, Catheter | 第 1 类 | 21 CFR 878.4200 | 4 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 第 1 类 | 21 CFR 878.4680 | 96 |
| GCZ | Retainer, Surgical | 第 1 类 | 21 CFR 878.4800 | 5 |
| GDC | Table, Operating-Room, Electrical | 第 1 类 | 21 CFR 878.4960 | 18 |
| GDF | Guide, Needle, Surgical | 第 1 类 | 21 CFR 878.4800 | 28 |
| GDG | Hook, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 10 |
| GDH | Gouge, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 6 |
| GDI | Dissector, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 7 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 32 |
| GDL | Needle, Suturing, Reusable | 第 1 类 | 21 CFR 878.4800 | 5 |
| GDM | Needle, Aspiration And Injection, Reusable | 第 1 类 | 21 CFR 878.4800 | 48 |
| GDN | Knife, Amputation | 第 1 类 | 21 CFR 878.4800 | 1 |
| GDO | Applier, Surgical, Clip | 第 1 类 | 21 CFR 878.4800 | 14 |
| GDR | Saw, Manual And Accessories | 第 1 类 | 21 CFR 878.4800 | 2 |
| GDT | Staple, Removable (Skin) | 第 1 类 | 21 CFR 878.4760 | 19 |
| GDW | Staple, Implantable | 第 2 类 | 21 CFR 878.4750 | 283 |
| GDX | Scalpel, One-Piece | 第 1 类 | 21 CFR 878.4800 | 26 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 第 1 类 | 21 CFR 878.4450 | 111 |
| GDZ | Handle, Scalpel | 第 1 类 | 21 CFR 878.4800 | 16 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 36 |
| GEC | Brush, Scrub, Operating-Room | 第 1 类 | 21 CFR 878.4800 | 37 |
| GED | Brush, Dermabrasion, Manual | 第 1 类 | 21 CFR 878.4800 | 2 |
| GEE | Brush, Biopsy, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 7 |
| GEF | Applier, Staple, Surgical, | 第 1 类 | 21 CFR 878.4800 | 4 |
| GEG | Elevator, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 12 |
| GEH | Unit, Cryosurgical, Accessories | 第 2 类 | 21 CFR 878.4350 | 263 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 第 2 类 | 21 CFR 878.4400 | 2314 |
| GEJ | Carrier, Ligature | 第 1 类 | 21 CFR 878.4800 | 5 |
| GEN | Forceps, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 104 |
| GEO | File, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 2 |
| GES | Blade, Scalpel | 第 1 类 | 21 CFR 878.4800 | 48 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | 第 1 类 | 21 CFR 878.4820 | 23 |
| GEX | Powered Laser Surgical Instrument | 第 2 类 | 21 CFR 878.4810 | 2876 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 第 1 类 | 21 CFR 878.4820 | 41 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 第 1 类 | 21 CFR 878.4820 | 27 |
| GFB | Head, Surgical, Hammer | 第 1 类 | 21 CFR 878.4820 | |
| GFC | Driver, Surgical, Pin | 第 1 类 | 21 CFR 878.4820 | 2 |
| GFD | Dermatome | 第 1 类 | 21 CFR 878.4820 | 12 |
| GFE | Brush, Dermabrasion, Powered | 第 1 类 | 21 CFR 878.4820 | 2 |
| GFF | Bur, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4820 | 16 |
| GFG | Bit, Surgical | 第 1 类 | 21 CFR 878.4820 | 3 |
| GFI | Osteotome, Manual | 第 1 类 | 21 CFR 878.4800 | 6 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | 第 1 类 | 21 CFR 878.4800 | 3 |
| HAB | Saw, Powered, And Accessories | 第 1 类 | 21 CFR 878.4820 | 2 |
| HAM | Apparatus, Electrosurgical | 第 2 类 | 21 CFR 878.4400 | 31 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 第 2 类 | 21 CFR 878.4580 | 28 |
| HBT | Applier, Hemostatic Clip | 第 1 类 | 21 CFR 878.4800 | 4 |