FDA 510(k) clearances — page 352
clearances on record, most recent first.
Clearances — page 352
35,101–35,200 of 176,542- K150866 — SURGISEAL Topical Skin Adhesvie
- K150909 — INTEGO Family and Accesories
- K151046 — illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
- K151101 — Lotus Series 4 Ultrasonic Surgical System & Accessories
- K151198 — A-CIFT SoloFuse
- K151486 — Biograph mCT and mCT Flow PET/CT Scanners
- K151505 — Coronis Uniti
- K151654 — PROW FUSION
- K151659 — ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
- K151681 — IntelliVue Patient Monitor
- K151685 — GUA60A, GU60A-65
- K151709 — Hi-Light Diagnostic Ultrasound Systems
- K142965 — Virtuoso System for IHC PR (1E2) using iScan HT
- K143011 — 2014 InterActive/SwishActive System
- K143103 — PROPENCIL Smoke Pencil
- K150128 — GC Ortho Connect, GC Ortho Etching Gel
- K150850 — Refobacin Bone Cement R
- K150953 — Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
- K151326 — RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
- K151377 — ActiveCare+SFT; ActiveCare+SFT HomeCare, ActiveCare+DTx; ActiveCare+DTx HomeCare
- K151523 — Uncoated Tubing and Connector Components
- K151557 — EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine
- K151660 — MultiFIX S Knotless Fixation System
- K151690 — Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
- K143115 — The VersaJet II Hydrosurgery System
- K150555 — BA400 14mm Abutment
- K150611 — MedSource ClearSafe Safety IV Catheter
- K150700 — ACP 1 Anterior Cervical Plating System
- K150878 — ILUMIEN OPTIS
- K150903 — EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
- K151021 — OsteoMed Cannulated Screw System
- K151418 — Monster Screw System
- K151616 — AT235
- K151622 — St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter
- K151677 — LnK Cervical Interbody Fusion Cage System
- K142190 — Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs +1 more
- K142398 — Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
- K150349 — Rapid Hair Removal Pads
- K150844 — Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
- K150983 — Pyrenees Cervical Plate System
- K151184 — InFill Interbody Fusion Devices
- K151196 — Nautilus Spinal System
- K151330 — Microlife Wrist Watch Blood Pressure Monitor
- K150084 — Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
- K150321 — EVOS Lumbar Interbody System
- K150367 — Neodent Implant System
- K150919 — ArgenZ Esthetic Plus
- K151014 — Aura DR 43C-AG flat panel detector
- K151091 — Vitrea Software Toshiba Package, VSTP-001A
- K142468 — Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System
- K142005 — SpineFab Vertebral Body Replacement (VBR) System
- K143213 — INOmax DSIR Plus MRI
- K143275 — IOLMaster700
- K143345 — SIGNA Pioneer
- K143355 — The Simple Locking IntraMedullary (SLIM) System
- K143719 — Aeroneb USB Contoller System
- K150590 — CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
- K150834 — Atrax Anterior Cervical Plating System
- K150912 — Houva-NET Control System
- K151340 — HARMONIC Focus Long Shears + Adaptive Tissue Technology
- K151566 — Abbott ARCHITECT Total T4 Calibrators
- K151572 — Penumbra Smart Coil
- K141133 — VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
- K141725 — BONGOLD BONE GRAFT MATERIAL
- K142764 — KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
- K142799 — Model BT-220L and BT-220C
- K143340 — Powder Free Vinyl Patient Examination Gloves, Yellow Color
- K143656 — StarCeram® Z-Nature, StarCeram® Z-Smile
- K150313 — Ablation Confirmation
- K150484 — Penguin In-Line Warmer
- K150655 — OIC Intramedullary Nail System
- K151037 — GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
- K151143 — EndoLIF On-Cage
- K151451 — Aplio 500/400/300 Diagnostic Ultrasound System V6.0
- K151581 — Leva Spacer System
- K151755 — OASYS(r) System
- K142970 — SterilContainer S System
- K143607 — I-Portal NOTC, VNG and VOG
- K150301 — NavSuite3 Kit
- K150423 — EXPAZEN
- K150480 — JO H20 Water Based Personal Lubricant
- K151513 — Arrow Endurance Extended Dwell Peripheral Catheter System
- K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
- K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
- K142705 — LeadCare Plus Blood Lead Testing System
- K143031 — mcompass Biofeedback Anorectal Manometry System
- K143070 — Disposable Safety Self-destructive Syringes, 5 ML
- K143202 — ANGIO-PRESS DVT Compression Device Model Name: IPCS
- K150661 — ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
- K150856 — Reform Pedicle Screw System
- K150907 — Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
- K150933 — iBond Universal & iBond Ceramic Primer
- K151054 — Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System
- K151233 — Monaco
- K151438 — Dentrix Ascend Imaging
- K151488 — Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
- K151530 — CardioChek Plus Test System
- K151543 — Graft Delivery Device with Integrated Stylet
- K143732 — FUJIFILM Endoscope Models EC-600HL and EC-600LS
- K150632 — Hypervisor IX Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.