FDA 510(k) clearances — page 351
clearances on record, most recent first.
Clearances — page 351
35,001–35,100 of 176,542- K142829 — Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification +6 more
- K142855 — Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
- K150251 — Barrx Anorectal RFA Wand
- K150394 — Tyber Medical Wedge System
- K150699 — Bard LubriGuard Foley Catheter
- K150715 — 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
- K150759 — Hyper-C Anterior Cervical Plate System
- K150861 — QBit Series Diagnostic Ultrasound System
- K151010 — Piccolo Composite Nailing System
- K151033 — Philips Self-Adhesive Electrodes
- K151105 — Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa
- K151118 — Smith and Nephew Legion Hinge Knee System
- K151150 — Elements
- K151207 — Proton Immobilization Solution
- K151447 — Axium Detachable Coil System
- K151464 — Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
- K151854 — 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display
- K143737 — EM25 - glute toning device
- K150014 — Serenity
- K150236 — Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
- K150924 — A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
- K151187 — QuadraSphere Microspheres
- K151698 — BD Angiocath IV Catheter, BD Insyte IV Catheter
- K151760 — Barricade Embolization Coil System
- K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
- K141427 — ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
- K142129 — RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
- K142726 — O Glide Personal Lubricant
- K142819 — Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
- K143082 — IV Administration Sets with 200(micro)m Blood Filter
- K143102 — Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
- K143120 — OrthoPulse
- K143193 — Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
- K143347 — Powder-Free Yellow Vinyl Patient Examination Gloves
- K150295 — LOCATOR RTx
- K150344 — Dentis Dental Implant System
- K150347 — Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
- K150486 — Halo
- K150906 — ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
- K150938 — Straumann® Dental Implant System ¿ Roxolid® SLA Implants
- K150968 — TRU Dental Implant System
- K151038 — EPX-Series Mobile X-ray System
- K151045 — TENEO Dental Treatment Unit and Accessories
- K151068 — SureLock W Suture Anchor
- K151146 — N-Force Fixation System
- K151395 — Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
- K151628 — Medline ENFit Connectors
- K140740 — TRANSONIC TISSUE PERFUSION MONITOR
- K141720 — iuStar300 Medical Ultrasound Diagnostic System
- K142962 — PROTOCOL Incision Dressing
- K143133 — RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
- K143383 — Q6 Edge EM
- K143735 — Digital Automatic Blood Pressure Monitor MD2300
- K150248 — ORL Video NasoPharyngo-Larngoscope
- K150742 — Muscle Stimulation System 110
- K150773 — E-CUBE 15 Diagnostic Ultrasound System
- K151314 — CinchLock Flex Knotless Suture Anchor
- K151532 — KYPHON ELEMENT Inflatable Bone Tamp
- K151730 — Magellan Robotic System
- K143143 — PATHWAY ELIF
- K143152 — TM-ABI system
- K143346 — Powder-Free White Vinyl Patient Examination Gloves
- K150370 — Nutra Light Advanced
- K150601 — Zeramic Adhesive Resin Cement
- K150613 — LaserCap LC Pro and LC Elite
- K150751 — Cordelle II Sound Processor
- K150875 — iFuse Implant System
- K151020 — Rampart-T Interbody Fusion System
- K151067 — Ventilation (Tympanostomy) Tubes
- K151107 — CoSense ETCO Monitor
- K151113 — ELITech Clinical Systems CALCIUM ARSENAZO
- K151676 — Retracta Detachable Embolization Coil
- K143033 — DENTCA DENTURE BASE
- K143268 — TENS AND POWERED MUSCLE STIMULATOR
- K143356 — NovoStitch Plus Meniscal Repair System
- K143650 — CooperSurgical Advincula Delineator Uterine Manipulator
- K150350 — Flexi-Seal Signal Fecal Management System
- K150365 — Cloud9 System
- K150537 — MiNi Internal Implant System
- K150587 — Cortex Laser System
- K151035 — PulseRelief
- K151094 — Mosaic Universal Composite
- K151858 — Caiman Seal and Cut Technology
- K141777 — NEODENT IMPLANT SYSTEM
- K142827 — Visi Mobile Monitoring System, Visi Mobile Chest Sensor
- K143322 — Medline Natural Lubricating Liquid
- K150066 — Exactech Alteon Monobloc Revision Stem
- K150088 — Evacore Fully Disposable Vacuum Assist Biopsy Device
- K150756 — Micro well group culture dish, 9-well; Micro well group culture dish, 16-well
- K150886 — Trojan Riviera Personal Lubricant
- K151696 — Caiman Seal and Cut Technology
- K151707 — EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
- K142651 — The Moses Express appliance
- K143176 — UltraLinq
- K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material
- K150245 — CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
- K150272 — Capnostream 35 Portable Respiratory Monitor
- K150380 — ProMIS Fixation System
- K150776 — Medrobotics Flex System
- K150839 — 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
Data sourced from openFDA. This site is unofficial and independent of the FDA.