FDA 510(k) clearances — page 308
clearances on record, most recent first.
Clearances — page 308
30,701–30,800 of 176,542- K162201 — Desara TV, Desara Blue TV
- K162261 — CERAMAGE UP
- K162387 — U-IGNITE Bladeless Trocar
- K162765 — Venus Velocity Diode Laser System
- K162810 — InSeca ARC Stylus, Aerin Console
- K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System
- K163128 — Epic Pro
- K163479 — R2P Metacross RX
- K160991 — Neo GBR System
- K162179 — osteo-WEDGE II ® Open Wedge Bone Locking Plate System
- K162805 — Akros Fibulink Syndesmosis Repair Kit
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
- K163120 — EPIQ 5 Diagnostic Ultrasound System +3 more
- K163252 — Mammomat Fusion with Stereotactic Biopsy
- K151857 — Love Alchemy's Love Lotion
- K161508 — Ceruloplasmin
- K161841 — D2P
- K161971 — Bindex BI-2
- K162083 — RII Multi-function Infrared Thermometer, Model TH52Z
- K162208 — DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
- K162483 — Symbia Intevo Bold
- K162767 — Sentinel BreastScan II System
- K162818 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
- K162819 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
- K161036 — Hospira Extension Set, Hospira Primary Set
- K161463 — SureClip(TM) Repositionable Hemostasis Clip
- K161504 — Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
- K162086 — MultiStim ECO
- K162181 — Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
- K162253 — Trapper Exchange Device
- K162490 — Disc-FX System
- K162887 — PrismaSATE
- K162931 — Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
- K162946 — 8ch Knee-Foot SPEEDER
- K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
- K163013 — Quantib Brain 1.2
- K163116 — Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
- K163141 — NAMIC ClearaCIL Contrast Injection Lines
- K163142 — SpeedStitch Suture Passer +2 more
- K163444 — Spectre guidewire
- K163456 — DuraGen Secure Dural Regeneration Matrix
- K163457 — NeuraGen 3D Nerve Guide Matrix
- K163490 — StatStrip Xpress 2 Glucose Hospital Meter System
- K163492 — Oracle EUS Balloon +4 more
- 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 +4 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.