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General, Plastic Surgery devices
466 product codes reviewed by the General, Plastic Surgery panel. 16,352 510(k) clearances and 6,898 recalls in the FDA data, 41% of those recalls name a 510(k).
358510(k)s in 12 months
415recalls in 12 months
2,795recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| LRO | General Surgery Tray | 2 | 0 | 104 |
| GEX | Powered Laser Surgical Instrument | 2 | 72 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 47 | 18 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 2 | 38 | 0 |
| OHT | Light Based Over-The-Counter Hair Removal | 2 | 16 | 0 |
| PUI | Drape, Surgical, Exempt | 2 | 0 | 16 |
| FYA | Gown, Surgical | 2 | 10 | 5 |
| GEH | Unit, Cryosurgical, Accessories | 2 | 10 | 5 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | 6 | 7 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 2 | 11 | 0 |
| FTC | Light, Ultraviolet, Dermatological | 2 | 4 | 4 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 1 | 7 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 7 | 0 |
| FXX | Mask, Surgical | 2 | 7 | 0 |
| NEU | Marker, Radiographic, Implantable | 2 | 4 | 3 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 | 6 | 0 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | 6 | 0 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | 5 | 0 |
| FSY | Light, Surgical, Ceiling Mounted | 2 | 0 | 5 |
| FZP | Clip, Implantable | 2 | 5 | 0 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 5 | 0 |
| GDW | Staple, Implantable | 2 | 5 | 0 |
| OKI | Emergency Response Safety Kit | 2 | 0 | 5 |
| OLI | Fat Reducing Low Level Laser | 2 | 5 | 0 |
| QPB | System, Suction, Lipoplasty For Removal | 2 | 5 | 0 |
| SCV | Modular Electromechanical Surgical System | 2 | 4 | 1 |
| OWW | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | 2 | 1 | 3 |
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | 2 | 3 | 1 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 2 | 4 | 0 |
| SAH | Magnetic Compression Anastomosis System | 2 | 4 | 0 |
| FYD | Apparatus, Exhaust, Surgical | 2 | 0 | 3 |
| GAP | Suture, Nonabsorbable, Silk | 2 | 0 | 3 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 2 | 1 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 0 | 3 |
| NEY | System, Ablation, Microwave And Accessories | 2 | 3 | 0 |
| OAB | Low Energy Direct Current Thermal Ablation System | 2 | 3 | 0 |
| ONO | Neurosurgical Laser With Mr Thermography | 2 | 3 | 0 |
| PZX | Left Atrial Appendage Clip, Implantable | 2 | 3 | 0 |
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | 2 | 3 | 0 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 | 0 |
| FWP | Prosthesis, Chin, Internal | 2 | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 2 | 0 | 2 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 2 | 1 | 1 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | 2 | 2 | 0 |
| NVK | Laser, Dental, Soft Tissue | 2 | 2 | 0 |
| OVN | Suture Kit | 2 | 0 | 2 |
| OWT | Mesh, Surgical, Absorbable, Abdominal Hernia | 2 | 2 | 0 |
| PEM | Dental Barriers And Sleeves | 2 | 2 | 0 |
| PZP | Fluid Jet Removal System | 2 | 2 | 0 |
| QAI | Powered Microneedle Device | 2 | 2 | 0 |
| QJF | Autofluorescence Imaging Adjunct Tool For Wounds | 2 | 1 | 1 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 2 | 2 | 0 |
| QSO | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | 2 | 2 | 0 |
| QUW | Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | 2 | 2 | 0 |
| SDD | Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | 2 | 2 | 0 |
| ESW | Prosthesis, Esophageal | 2 | 1 | 0 |
| FTA | Light, Surgical, Accessories | 2 | 0 | 1 |
| FTM | Mesh, Surgical | 2 | 1 | 0 |
| LZK | Implant, Malar | 2 | 0 | 1 |
| NUV | Massager, Vacuum, Light Induced Heating | 2 | 1 | 0 |
| NWA | Prosthesis, Tracheal, Preformed/Molded | 2 | 1 | 0 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 2 | 1 | 0 |
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | 2 | 1 | 0 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 2 | 1 | 0 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | 1 | 0 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 2 | 1 | 0 |
| OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | 2 | 1 | 0 |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 2 | 1 | 0 |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | 2 | 1 | 0 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 2 | 1 | 0 |
| PGZ | Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use | 2 | 1 | 0 |
| PMC | Scalp Cooling System | 2 | 1 | 0 |
| QDG | Parathyroid Autofluorescence Imaging Device | 2 | 1 | 0 |
| QVS | Breast Implant Suction Retrieval Device | 2 | 1 | 0 |
| QWJ | Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament | 2 | 1 | 0 |
| QZS | Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer | 2 | 0 | 1 |
| SAB | Table Mounted Miniaturized Electromechanical Surgical System | 2 | 1 | 0 |
| SGZ | Ultraviolet Lamp Products | 2 | 1 | 0 |
| SHA | Solid Wound Dressing With Permanently Bound Antimicrobial Agent | 2 | 1 | 0 |
| SHY | Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. | 2 | 1 | 0 |
| SIR | Integrated Operating Table-Electromechanical Surgical System | 2 | 1 | 0 |
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