FDA 510(k) clearances — page 300
clearances on record, most recent first.
Clearances — page 300
29,901–30,000 of 175,699- K163492 — Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear
- K160469 — AGNES
- K160536 — Chaorum Implant System
- K161202 — C2 Cryoballoon Ablation System
- K161536 — EasyOne Air Spirometer
- K161637 — Poseidon OCT Spinal Fixation System
- K161641 — LOSPA IS ACP System
- K162064 — CrossBay IVF Embryo Transfer Catheter Set
- K162146 — Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
- K162561 — Turbo-Power (2.0mm) Laser Atherectomy Catheters
- K162563 — YOGA Microcatheter
- K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
- K162763 — Vevazz LED Heat Lamp
- K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
- K163114 — Sapphire II PRO
- K163253 — Arterys Cardio DL
- K163454 — ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
- K153184 — Caremed Reusable & Disposable SPO2 Sensors
- K161270 — CephSimulation
- K162223 — Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)
- K162234 — Truscope Ultra Patient Monitor
- K162770 — Relign System
- K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
- K163396 — ACUSON P500 Ultrasound System
- K163410 — DigitalDiagnost C50
- K163424 — AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
- K163429 — B6
- K162084 — MOTO Partial Knee System
- K162423 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
- K162704 — Axium Prime Detachable Coil System
- K163408 — Isolator Multifunctional Linear Pen
- K163421 — syngo.via MI Workflows
- K163427 — X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
- K161654 — NuFACE Gel Primer
- K162604 — Cranial Reducing Tubes
- K162702 — Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table
- K162940 — MultiBand SENSE
- K162180 — Disposable Insulin Syringe
- K162375 — Envision 3D: Image Guidance System
- K162531 — STERISPINE CC
- K163180 — Hubble II
- K160972 — Gexfix External Fixation
- K161613 — Hang&Go PAC
- K161959 — ClearView cCAD
- K162675 — Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
- K162686 — Kuschall Champion Manual Wheelchair
- K162692 — Kuschall K-Series Attract Manual Wheelchair
- K162696 — Kuschall Advance Manual Wheelchair
- K163028 — Medline ReNewal Reprocessed Stryker External Fixation Devices
- K161789 — BLUEPRINT Patient Specific Instrumentation
- K163308 — SMARTO
- K162688 — Sysmex CS-2100i
- K160231 — Model X-100C CO-Met Oximetry System
- K161299 — BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
- K162193 — XenMatrix AB Surgical Graft
- K162233 — Kurin Blood Culture Collection Set
- K162772 — ARIES GBS Assay
- K163000 — AMPLATZER TorqVue 45x45 Delivery Sheath
- K163018 — Zilver 635 Biliary Stent
- K163055 — Reprocessed Kendall SCD Express Foot Cuff
- K163539 — Ez3D-i / E3
- K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
- K160309 — Neurosoft TMS
- K160538 — Sysmex XN-L Automated Hematology Analyzer
- K160585 — XN CAL
- K160586 — XN-L CHECK
- K160588 — XN CHECK BF
- K160590 — XN CHECK
- K160925 — VPS Rhythm Device with TipTracker Technology
- K160949 — Go Dose System
- K160981 — Patient Monitor
- K160982 — Sphynx
- K161032 — neon3 universal OCT spinal stabilization
- K161127 — The Small PLATEAU (PLATEAU-C) Spacer System
- K161399 — Neocis Guidance System
- K161467 — HydraGuard 10 UltraFilter
- K161550 — DynaMesh-VENTRAL
- K161639 — Y-MIC
- K162022 — Collagentex Rx-1
- K162282 — CardioChek Plus Test System, CardioChek Home Test System
- K162352 — derma+flex QS High Viscosity Tissue Adhesive
- K162446 — FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System
- K162478 — ivWatch
- K162721 — Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
- K163068 — pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
- K163306 — Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable
- DEN150055 — AeroForm Tissue Expander System
- DEN160020 — CipherOx CRI Tablet
- K152778 — TRACOE Cuff Pressure Monitor
- K153426 — Ox-Imager CS
- K160942 — Sonablate
- K161197 — Orthodontic Screw
- K161215 — Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs
- K161307 — NICO Myriad
- K161566 — DMS Disposable Subdermal Needle Electrodes
- K161716 — TEETHAN 2.0
- K161723 — ulrich Transfer Set
- K161916 — TelePatch Cardiac Monitor
- K161928 — CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
- K162003 — IMSE Cervical Cage
Data sourced from openFDA. This site is unofficial and independent of the FDA.