FDA 510(k) clearances — page 285
clearances on record, most recent first.
Clearances — page 285
28,401–28,500 of 176,542- K172671 — HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
- K172691 — Ultrasonic Generator
- K172016 — Force Fiber Fusion Suture
- K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
- K172285 — Ablatherm Fusion
- K172621 — HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
- K172684 — Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem
- K172884 — Arisure Closed Vial Adapter
- K163183 — Yooeehouse Breast Pump
- K170054 — iSurg
- K170375 — Nobilplast Denture Resin
- K170506 — ECG Check - Universal, ECG Check - Universal Plus
- K170873 — Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl
- K171250 — BRIDALVEIL Occipital Cervical Thoracic System
- K171768 — Trident® II Acetabular System
- K171978 — Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
- K172210 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K172596 — Large Screws Range
- K163326 — SmartEP
- K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) System
- K170119 — Calix Lumbar Spinal Implant System
- K170166 — CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
- K170505 — SecurePortIV Catheter Securement Adhesive
- K171309 — BR-FHUS Navigation 1.0
- K171408 — Carbon Monoxide Breath Sensor System (COBSS)
- K171440 — Berkeley VC-10 Vacuum Curettage System
- K171463 — ASPIRE Bellus II
- K171685 — Med4 Elite
- K171792 — Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
- K171795 — Thommen Implant System
- K172065 — SCARLET AC-T
- K172080 — Photoelectric Therapy System
- K172309 — Endoscopic Ultrasound Aspiration Needle
- K172342 — Voluson E6, Voluson E8, Voluson E10
- K172380 — U2 Diagnostic Ultrasound System
- K172397 — Sherlock 3CG Tip Positioning System Stylet
- K172420 — Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
- K172631 — Arisure Dry Spike
- K161434 — Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
- K163442 — Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
- K163455 — SurgiCube
- K170020 — Peel-Away Introducer Set
- K170262 — Digital Thermometer
- K170498 — Gems Oocyte Retrieval Buffer ORB-20, ORB-50
- K170802 — TRAUMACEM V+ Injectable Bone Cement
- K171212 — AirFit N20
- K171633 — NuVasive TLX Interbody System
- K171728 — MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm
- K171894 — NuVasive® Precept Spinal System
- K171922 — Anatotemp Anatomic Dental Implant Healing Abutment
- K171965 — Resection Electrodes with HF cable
- K172595 — CUSA Excel+ Ultrasonic Surgical Aspirator System
- K172612 — FiberTak DX
- K172659 — MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
- K170183 — Cetus system, Cetus probe
- K170482 — Spider Frame External Fixation System
- K170810 — CRYOFOS
- K171211 — OIC External Fixation System
- K171215 — QiF Blood and Fluid Warmer
- K171661 — Scopis Extended Instrument Set EM
- K171936 — Peerbridge Cor(TM) System
- K171941 — FreeStyle Precision Neo Blood Glucose Test Strips
- K172109 — Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
- K172275 — Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
- K170162 — Vesco Medical Nasoenteric Feeding Tubes
- K170816 — Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
- K171107 — CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
- K171963 — Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
- K171992 — SculpSure
- K172015 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
- K172101 — ROMEO® 2 Posterior Osteosynthesis System
- K172581 — CareView 1800Cw X-ray Flat Panel Detectors
- K163270 — ISEN-Goggles with Data Viewer
- K163577 — Ecofit® Hip System
- K170157 — INDEPENDENCE® Spacers
- K170985 — Urbanek Device
- K171161 — Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)
- K171442 — Exofin Fusion Skin Closure System
- K171726 — LapBag
- K171862 — GALAXY G3 Mini Microcoil Delivery System
- K171943 — Electrocardiograph
- K172126 — Xpert Xpress Strep A
- K172628 — PRECICE System
- K171460 — Powder-free Clear Vinyl Patient Examination Gloves
- K162848 — Straumann CARES Golden Ti/TiN Abutments
- K162956 — NOWCARDIO SYSTEM
- K163674 — Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
- K170758 — Thermage FLX System and Accessories
- K170956 — SYSTEM 1E Liquid Chemical Sterilant Processing System
- K171262 — TempSure
- K171303 — Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
- K171499 — Occlusion Detection Dressing Kit
- K171599 — WiTouch Pro, WiTouch, Neubac
- K171986 — Sterling Supreme Diode Laser
- K172086 — Matira Anterior Cervical System
- K172544 — IV Fat Emulsion Administration Sets
- K172545 — SERI Contour
- K172571 — ULTRASCORE Focused Force PTA Balloon
- K161719 — Salter Labs Bubble Humidifier
- K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
Data sourced from openFDA. This site is unofficial and independent of the FDA.