FDA 510(k) clearances — page 343
clearances on record, most recent first.
Clearances — page 343
34,201–34,300 of 175,770- K150641 — MagVita TMS Therapy System
- K150752 — GME ExSys 308
- K150874 — NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
- K151053 — PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner
- K151204 — HEMO-Bandage
- K151363 — Zephyr Vascular Compression Device
- K151483 — Biomet Spine Fusion System
- K151568 — Arthrex OrthoVis Preoperative Plan
- K151813 — Sniper Spine System
- K151904 — SyncVision System
- K151963 — SmartSite Vented Vial Access Device
- K142790 — OneTouch Lubricant Gel
- K150316 — Polypectomy Snare
- K150371 — Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
- K151177 — XenMatrix AB Surgical Graft
- K151199 — SmartDrive Wheelchair Power Assist
- K151298 — Gemini XXP-HP
- K151883 — 5MP Monochrome LCD Monitor, RadiForce GX540
- K151889 — Infinity ERCP Sampling Device
- K143277 — Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),
- K143278 — LnK Posterior Cervical Fixation System
- K143368 — GenIQ
- K150107 — Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
- K150377 — Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor
- K150505 — Cellfina System
- K151015 — ECHELON Oval V 5.0 MRI System
- K151808 — 3D/5D Viewer
- K151829 — Atlas SPEEDER Header/Neck
- K142829 — Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.