FDA 510(k) clearances — page 347
clearances on record, most recent first.
Clearances — page 347
34,601–34,700 of 175,770- K150882 — Edwards Suture Fastening System
- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K142751 — Chang Gung ComMed Series Dental Implant System
- K143090 — LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
- K150184 — Dymaxeon Spine System
- K150199 — Neodent Implant System
- K150303 — XXL Vascular Balloon Dilatation Catheter
- K150630 — Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
- K141943 — BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
- K142416 — Luma Wrap
- K142598 — Opto Wire and OptoMonitor System
- K142626 — Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters
- K142679 — CARESCAPE R860
- K142783 — HEARTWAY Electrically Powered Wheelchair P27
- K142835 — Iliad Pedicle Screw System and Zenius Pedicle Screw System
- K150080 — DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
- K150319 — MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
- K150376 — Sonoma Cancellous Bone Screw and Washer
- K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
- K150414 — Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL
- K150415 — NilRead
- K150496 — Total Knee Arthroplasty System
- K150582 — Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
- K150616 — Trevo XP ProVue Retriever (4x30mm)
- K150718 — Wi-3 HAL-RAR System
- K151238 — JUSHA-M23C LCD Monitor
- K141332 — Captiva Spine SmartLOX Cervical Plate System
- K142512 — Personalized Physiology Analytics Engine software
- K142577 — PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
- K142645 — Avenue T TLIF Cage
- K143559 — XP1000 RF
- K150135 — DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
- K150216 — Synergy Cranial
- K150250 — SternSnap Angled Attachment
- K150280 — PulmoVia Working Channel
- K150362 — NuVasive CoRoent Small Interbody System
- K150373 — Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]
- K150489 — EOS PMP, EOS PMP Integrated
- K150548 — Tek RMD (Tek Robotic Mobilization Device)
- K151244 — Pre-Formed Guidewire
- K142920 — KM Needles (Acupuncture Needle)
- K143572 — Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
- K143730 — GBR System
- K150569 — LaparoVue
- K150867 — Affixus Tibial Nailing System
- K151253 — 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
- K151260 — ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
- K151291 — BD Veritor (TM) System for the Rapid Detection of Flu A+B
- K141292 — Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System
- K142269 — Reliance Cervical IBF System
- K142559 — ELEVATE Spinal System
- K142770 — Powered Wheelchair
- K142906 — APTUS Wrist 2.5 System
- K143520 — SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)
- K150034 — AMT Enteral Transition Adapters
- K150393 — TETRIC EVOFLOW BULK FILL
- K150578 — Capillus 272 Office Pro
- K150593 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
- K150625 — Morrison Steerable Needle
- K150662 — Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
- K150753 — OASYS System
- K151240 — extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc
- K132058 — VIDAS FT4
- K142327 — smARTrack Feeding Tube System
- K143466 — Hemogrip Patch
- K150466 — ZX2 Laser System
- K150643 — Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
- K150725 — Visaris Avanse
- K150939 — Ensizor Endoscopic Scissors
- K151301 — BD Veritor System Flu A+B Assay
- K151082 — MicroCross Catheter
- DEN130033 — COGNIVUE
- K140021 — TI-OSS
- K142503 — IMED-Z FLUID STATUS MONITOR
- K142518 — HumaPen Luxura
- K143002 — Metallic Locking Bone Plate and Screw System
- K143380 — Phasix ST Mesh
- K143715 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K150109 — Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
- K150140 — MCL 31 Dermablate
- K150186 — Chariot Guiding Sheath
- K150294 — DPZ Pedicular Fixation System
- K150332 — FreeStyle Lite Blood Glucose Monitoring System
- K150517 — Freedom Spinal Cord Stimulator System
- K150531 — FreeStyle Freedom Lite Blood Glucose Monitoring System
- K150761 — Ez3D-i/E3
- K151001 — MUSE System
- K151060 — Ultrasound System SONIMAGE HS1
- K151203 — Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
- K142446 — Fixtemp Cement
- K142595 — VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
- K142833 — INTRAGen
- K143041 — Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
- K143570 — WIRION
- K143590 — Alevicyn SG Antipruritic Gel
- K150012 — CreoDent Solidex Customized Abutment
- K150266 — Remington Medical Inc. Tuohy Epidural Needles
- K150443 — ToeTac Hammertoe Fixation System
- K150472 — NxStage System One
- K150552 — ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.