FDA 510(k) clearances — page 287
clearances on record, most recent first.
Clearances — page 287
28,601–28,700 of 175,699- K163334 — LiDCOunity v2 Hemodynamic Monitor
- K170441 — ElectroTek
- K171013 — Revolution ACT
- K162395 — MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
- K162681 — Enobio Wireless EEG
- K162759 — KeraStat(R) Gel
- K163470 — Galvanic Spa, Model: SKB-1405
- K163512 — Zio AT ECG Monitoring System
- K163585 — Responsive Orthopedics Total Hip Arthroplasty System
- K163639 — LS-5 ePTFE Suture
- K170001 — Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
- K170026 — Radiopaque Tissue Marker
- K170130 — Dynamic Coronary Roadmap
- K170311 — Reprocessed Agilis NxT Steerable Introducer
- K170395 — Talos® Lumbar (HA) PEEK IBF Devices
- K170655 — Zepto
- K170726 — Biopsy Forceps
- K170877 — Parcus SLiK Fix Screw
- K170890 — TELIX K Interbody System
- K170973 — VitalWatch Software User Interface
- K170995 — Electrocardiograph
- K171060 — OrthoButton AL
- K171101 — Closed Male Luer
- K171157 — PolyDev Soft Contact Lenses
- K171308 — Tubing Pack
- K171438 — Palisade Pedicular Fixation System
- DEN160043 — Sentinel Cerebral Protection System
- K162389 — Medcomp Vessel Dilator
- K162682 — MATISSE Anterior Cervical Interbody Fusion Cage System
- K162954 — OARtrac System with Patient Specific Reusable Universal PSD Sensors
- K163609 — Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
- K170158 — PowerGlide ST Midline Catheter
- K170200 — Carbon Dioxide Reagent Set
- K170203 — System, Applicator, Radionuclide, Remote Controlled
- K170490 — Celesteion, PCA-9000A/3
- K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
- K170656 — Reinforced Flexible Collagen Nerve Cuff
- K170711 — ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System
- K170741 — GTK Disposable Needle Guides
- K170904 — Biograph Horizon PET/CT
- K171053 — syngo Dynamics Version VA30
- K171344 — Xenocor Xenoscope Laparoscopic System
- K162601 — Infusion Set for Single Use
- K162684 — SL 220
- K163482 — Orthodontic Acrylic 2
- K170007 — Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
- K170278 — OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
- K170573 — Empowr CR Knee Tibial Insert
- K170626 — Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
- K170658 — Lympha Press Optimal Plus
- K170670 — Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
- K170698 — ALLY(TM) Bone Screws
- K171268 — Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
- K171338 — B R A H M S PCT sensitive KRYPTOR
- K171387 — EMS100 Tri-Wave Combination Stimulator
- K171388 — EndoWrist Stapler 45 System and Stapler 45 Reloads
- K162574 — AmCAD-US
- K163356 — Pulse* Spray Infusion System, Uni*Fuse Infusion System
- K163505 — ARIETTA PRECISION
- K163702 — Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
- K170521 — TRINITY/3D PROSTATE SUITE
- K170604 — FilmArray Respiratory Panel 2 (RP2)
- K170695 — VenaCure EVLT NeverTouch Direct Introducer Sheath
- K170899 — 27HJ713S
- K170954 — Portable ECG Monitor
- K171306 — gammaCore-S
- K171314 — QLAB Advanced Quantification Software
- K162448 — White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
- K162526 — Creatine Kinase-MB
- K162603 — Masimo O3 Regional Oximeter System
- K163065 — T3 Software
- K163140 — SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
- K163349 — MIS V3 Conical Connection Dental Implant System
- K170093 — AcceleDent Optima
- K170133 — FFR V2.5
- K170178 — Ultravision Visual Field Clearing System
- K170216 — Flexitouch System
- K170659 — IQ Technologies
- K170692 — Respire Pink Series with DentiTrac
- K170839 — RAPID Web
- K171059 — Nova StatSensor Creatinine Hospital Meter System
- K171217 — DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
- K171229 — DELL UP3017 with QUBYX PerfectLum bundle
- K171230 — My Dose Coach
- K171234 — Mistral-Air Warming Unit
- K171294 — da Vinci X Surgical System
- K171296 — SutureTape
- K170242 — MultiGen 2 RF Generator System
- K170259 — TruAbutment DS
- K170486 — CATHTONG II PICC Catheter
- K170557 — GenePOC GBS LB
- K170558 — revogene
- K170597 — PicoWay Laser System
- K170611 — SETx Pedicle Screw System
- K170892 — Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
- K170944 — LCD Monitor (MD310C, MD310G, MD210G)
- K171170 — M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
- K171238 — KARL STORZ ICG Imaging System
- K171253 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
- K162409 — Gems Vitrification Set, Gems Warming Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.