FDA 510(k) clearances — page 288
clearances on record, most recent first.
Clearances — page 288
28,701–28,800 of 176,542- K171592 — CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
- K171741 — Laport
- K171896 — Feminine Personal Trainer (FPT)
- K162543 — Reverse Pull Adjustable Facemask
- K170010 — Salle Intraoperative Pyeloplasty Stent Set
- K170722 — Moxxly Flow Collection System
- K170987 — Captus Vascular Retrieval System
- K171181 — PROCOTYL® PRIME E-CLASS XLPE Liner
- K171561 — Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload
- K171567 — IRIX-A Lumbar Integrated Fusion System
- K172131 — 2 Hole Lateral Plating System
- K160378 — BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
- K161298 — ShenDa Sinuscope
- K163441 — Locking Cage, Full XPE Cup
- K163647 — Revolve Envi 600 Advanced Adipose System
- K170136 — Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
- K171104 — Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
- K171124 — Nihon Kohden Wireless Input Unit WEE-1200
- K171191 — Hexagen Derm
- K171346 — Sapphire Sets
- K171487 — Sirius MRI Marker NS
- K171560 — OTIS Optical Coherence Tomography System
- K171716 — SKR 3000
- K172002 — Catalys Precision Laser System
- K172073 — Hi-Torque Command 18 Guide Wire
- K172207 — Standard Supreme Sterilization Wrapper
- K172327 — VMA System version 3.0
- K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small
- K170750 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication +4 more
- K171048 — RS80A Diagnostic Ultrasound System
- K171173 — OrthoPediatrics Titanium PediPlates® System
- K171249 — Entrada hip stem
- K171299 — Fixone Biocomposite Anchor
- K171331 — NxStage System One
- K171465 — Stryker Self-Punching ICONIX
- K171563 — MagnetOs Putty
- K171853 — Liver Access and Biopsy Sets
- K171865 — F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
- K171921 — VenaCure EVLT NeverTouch Procedure Kit
- K172061 — PRECICE UNYTE System
- K172386 — 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
- K170876 — Passport Series Patient Monitors(Passport 12m, Passport 17m)
- K170984 — LG BEAUTY LED MASK
- K171244 — Physiotrace
- K172104 — Ozark(tm) Cervical Plate System
- K172214 — Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
- K172227 — Endoscopic Injection Needle
- K172262 — EVOS Small Fragment Plating System
- K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
- K163342 — i-STAT Hematocrit test with i-STAT Alinity System
- K163695 — Borrelia B31 ViraChip IgM Test Kit
- K170642 — GRAVITY Soft Tissue Repair System
- K170911 — NEOCERA Advanced Barrier Cream
- K171041 — SilverSeal
- K171140 — Matrixx System
- K171504 — VERIFY Assert VH2O2 Self-Contained Biological Indicator
- K171523 — Monopolar Single Use Laparoscopic Instrument
- K171587 — VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
- K171617 — OKI Surgical Planning Software
- K171895 — Grivamax Hair Growth System
- K172364 — EzDent-i / E2 / Prora View
- K172367 — Stryker Integrated Bipolar Cord and Tubing Sets
- K163375 — INFINITY OCT System
- K171024 — ShockPulse-SE Lithotripsy System
- K171225 — Sorbact Wound Dressing-Ribbon Gauze
- K171276 — Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs
- K171452 — MAMBA and MAMBA FLEX Microcatheters
- K171459 — Ceribell Instant EEG Headband
- K171511 — RIDA GENE Norovirus GI/GII
- K171526 — Zenius, lliad and Kora Spinal Fixation Systems
- K171897 — Approach CTO Microwire Guide
- K172107 — Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Palisade Pedicular Fixation System
- DEN160025 — ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
- K161679 — s LDL-EX SEIKEN
- K163359 — ARK Methotrexate Assay
- K163418 — Diazyme DZ-Lite Total beta-hCG Test System
- K170003 — Zip 4 Skin Closure Device
- K170149 — 3DMetal Tibial Cones
- K170431 — CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
- K170667 — QEVO System with KINEVO 900
- K170782 — Medline UNITE® Snap-Off Screws
- K170800 — NuVasive LessRay with Enhanced Tracking
- K170825 — SnoreRx
- K171143 — Relievant Medsystems RF Generator
- K171183 — OmniTom
- K171227 — StarWalker
- K171261 — ScannerSide DoseCheck
- K171406 — Optum TeleHealth Application
- K171407 — ExsoMed ArcPhix and ExsoMed ArrowPhix
- K171660 — Duo Lumbar Interbody Fusion Device
- K171738 — Supria True64
- K171845 — EMBA Hourglass Peripheral Embolization Device
- K171898 — Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
- K171900 — Acclarix AX4 Diagnostic Ultrasound System
- K172139 — Streamline OCT Occipito-Cervico-Thoracic System
- K172182 — QUANTIEN Measurement System
- K172194 — Connector System
- K172216 — ACIST RXi Mini System
- K172359 — UroLift System (UL500)
Data sourced from openFDA. This site is unofficial and independent of the FDA.