FDA 510(k) clearances — page 295
clearances on record, most recent first.
Clearances — page 295
29,401–29,500 of 176,542- K170661 — Novosyn Quick Absorbable Suture
- K170681 — Continuous Single Culture -NX (CSCM-NX)
- K170763 — Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
- K170821 — ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System
- K170961 — NuVasive CoRoent Small Interlock II System
- K170967 — Intraskan DC Plus
- K171066 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K171086 — Accuray Precision Treatment Planning System
- K171112 — Trifore(tm) Cervical Plating System
- K171222 — Vitrea Software Toshiba Package; VSTP-001A
- K171256 — Quingo Flyte Mobility Scooter
- K160673 — Insulin Algorithms System
- K162109 — Kwart Retro-Inject Ureteral Stent
- K162564 — Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System
- K163357 — OneTouch Via On-Demand Insulin Delivery System
- K163531 — Advanced Perfusion System 1
- K163679 — Digital Automatic Blood Pressure Monitor MD3600
- K170144 — StentBoost Live
- K170250 — SmartTarget
- K170354 — Straumann Variobase Abutments
- K170356 — Straumann Variobase Abutments
- K170412 — Vantage Titan 1.5T, MRT-1510, M-Power GX
- K170602 — Continuous Single Culture-NX Complete (CSCM-NXC)
- K170728 — E. HISTOLYTICA QUIK CHEK
- K170736 — HySil Impression Materials
- K170751 — MRIdian Linac System with 138-leaf Collimator
- K170772 — Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
- K171088 — Cochlear Baha SoundArc
- K171335 — Venture 038 catheter
- K171353 — CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris
- K171357 — SurgiMend PRS Meshed, Revize-X
- K161420 — MOVES SLC
- K162372 — QT Ultrasound Breast Scanner-1
- K163603 — Digital Thermometer
- K170044 — Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
- K170155 — EK12 Algorithm
- K170374 — SonoBook Series Diagnostic Ultrasound System
- K170591 — Altomed Malhotra Platinum Segments
- K170687 — Flower Bone Screw Set
- K170709 — CURVE Laser System
- K171347 — Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
- K171429 — Magnetic Surgical System
- K163228 — APVolution System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.