FDA 510(k) clearances — page 279
clearances on record, most recent first.
Clearances — page 279
27,801–27,900 of 175,699- K171496 — Tritanium C Anterior Cervical Cage
- K172372 — QuadraSphere Microspheres
- K172375 — MicroSTAAR Injector System Cartridges
- K172394 — Steerable Guide Catheter
- K163464 — Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
- K163525 — QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
- K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System
- K172048 — FluidSmart
- K163302 — Senographe Pristina
- K163338 — OMNIBotics Knee System
- K163439 — NaviENT
- K163448 — GrindCare System
- K170181 — Prizma
- K170210 — PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
- K170547 — Arthrex Mesh Plate System
- K170970 — Epilaser
- K171117 — Carefusion NeutraClear Needle-free connector (EL-NC1000)
- K171323 — BIOPHOTAS CELLUMA3
- K171358 — Emprint SX Ablation Platform and Accessories
- K171507 — CustomizedBone Service
- K171558 — ExsoMed ITN Cannulated Screw System
- K171583 — RhythmView Workstation
- K162533 — Kelowna GYN and Crook Prostate Templates
- K162613 — Integrated Catch-up Freedom Syringe Driver Infusion System
- K163337 — Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
- K163402 — NLZ Motor System
- K163423 — Orthopantomograph OP300
- K170031 — Internal Octa Implant System
- K170599 — SureFlo EVD Catheter
- K171010 — Latitude EV Total Elbow Arthroplasty
- K171224 — Arctic Sperm Cryopreservation Medium
- K171570 — Additional VIPER PRIME screws with fenestrations
- K171642 — Atellica IM Ferritin Assay
- K171704 — CAPRI Corpectomy Cage System
- K171791 — MAGEC® System
- K172033 — Pirouette High Pressure (HP)
- K172055 — DUS-7000 Digital Color Doppler Ultrasound System
- K172098 — Medical Video Endoscope System
- K172106 — SHOFU MZ Primer Plus
- K163485 — SmartTouch
- K163628 — Idylla Respiratory (IFV-RSV) Panel
- K170467 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K170564 — MyndMove System, MyndMove Functional Electrical Stimulator
- K171321 — K2M Navigation Instruments
- K171540 — Refobacin Bone Cement R
- K171626 — truFreeze System
- K171985 — Astroglide O Oil Personal Lubricant & Massage Oil
- K172021 — LigaPASS
- K172049 — CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
- K172274 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL
- K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
- K162943 — SyMRI
- K163385 — Cortex Dental Implant System
- K170958 — ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
- K171039 — Assut Filbloc Permanent Sutures
- K171329 — Altus Spine Titanium Interbody Fusion System
- K171506 — Easyscreen
- 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; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.