FDA 510(k) clearances — page 341
clearances on record, most recent first.
Clearances — page 341
34,001–34,100 of 175,770- K150274 — GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
- K150658 — Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
- K150823 — EDLENi Intra-Oral Sensor
- K151008 — LINK® MEGASYSTEM-C®
- K152070 — BioZorb LP Marker
- K152071 — NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
- K152076 — PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
- K152081 — Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
- K152165 — S9 Portable Digital Color Doppler Ultrasound System
- K142351 — 25-Hydroxy Vitamin Ds EIA
- K142760 — Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
- K143648 — BD MAX Enteric Parasite Panel, BD MAX Instrument
- K150971 — Zekang Self-adhesive Electrode
- K151345 — BioGuard Air/Water Valve, BioGuard Suction Valve
- K151797 — Nuocande Plastic Manual Wheelchair Model NKD L07
- K152097 — Retraction Aspirator
- K150205 — LED Curing Light
- K150685 — Skynector CPAP Mask
- K151343 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
- K143348 — BC-3600 Auto Hematology Analyzer
- K143444 — SynePure Wound Cleanser
- K143487 — Lifelines iEEG
- K143529 — UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
- K143692 — GranOSTM - beta tricalcium phosphate synthetic bone granules
- K150673 — SYNFIX Evolution Secured Spacer System
- K150704 — PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
- K151087 — CS 8100SC, CS8100SC Access
- K151213 — UCP Drug Test Mini Cups
- K151333 — LightStim for Pain LED Belt
- K151422 — Reform Pedicle Screw System
- K151516 — Capillus82
- K151756 — STERISPINE LC CAGE
- K152045 — SALVATION® External Fixation System
- K141017 — PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,
- K143325 — OC-Light S FIT
- K143354 — Natrelle 133 Plus Tissue Expander
- K143556 — Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
- K150481 — Cascadia Interbody System
- K150648 — Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
- K151117 — Laparoscope Lens Shield Device
- K151153 — Pirouette 018
- K151243 — STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
- K151341 — Turbo High-Flow Non-coring Needle
- K151346 — Frontier Medical Devices Posterior Cable Screw System
- K151741 — HA Minuteman G3 MIS Fusion Plate
- K152186 — HealthMyne PACS
- K150220 — STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
- K150519 — ManipulatOR PRO, ManipulatOR
- K151180 — ScandiDos Delta4 Phantom+
- K151371 — Corporate Dental Imaging (CDI) Application
- K151837 — CS 3D Imaging
- K151998 — TraceIT Tissue Marker - 3mL
- K152033 — Cook ECM Powder
- K152209 — FUJIFILM SonoSite X-Porte Ultrasound System
- K143289 — NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
- K143729 — SterilContainer S
- K150311 — Full Automatic (NIBP)Blood Pressure Monitor
- K150621 — OsteoSelect PLUS Demineralized Bone Matrix Putty
- K151009 — Nexus Suture
- K151140 — LnK Lumbar Interbody Fusion Cage System
- K151166 — Instru-Safe Instrument Protection System
- K151348 — Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
- K151463 — Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
- K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
- K142995 — SOPIX
- K150767 — EDOSE
- K150986 — Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
- K151332 — Nexus Universal, Nexus Universal Chroma
- K151598 — VesselNavigator Rel. 1.0
- K143538 — MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
- K143613 — PaxWire Occlusion Balloon System
- K150043 — Transcutaneous Electrical Nerve Stimulators (TENS)
- K150169 — Sertera Biopsy Device
- K150432 — IDODENTINE DISC, IDODENTINE BLOCK
- K150728 — XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
- K150810 — Vyntus / SentrySuite Product Line
- K150857 — Banana Gold
- K151172 — MASTERGRAFT Contain
- K151309 — Wartie Advanced Wart Remover or other proprietary name
- K151372 — Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
- K152044 — Flexor Radial Hydrophilic Introducer Access Set
- K143233 — Mitsar-EEG
- K143446 — Accu-Chek FlexLink Plus infusion set
- K143458 — Neurosplint
- K143623 — Narval Brux
- K150452 — ComboCath OTW PTA Dilatation Catheter
- K150584 — Stryker Suture Tape
- K150695 — Modpod
- K150703 — CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
- K150847 — Foundation Interbody Devices
- K151056 — Aesculap T-Space PEEK and XP Spinal System
- K151142 — IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID
- K151200 — STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K151277 — Airlock® osteosynthesis plate system
- K151316 — U2 Hip Stem, Ti Porous Coated, Matrix
- K151379 — Conventus PRS System
- K151380 — syngo.via RT Image Suite
- K151448 — Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
- K151533 — Respiratory Gating for Scanners
- K151642 — Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Data sourced from openFDA. This site is unofficial and independent of the FDA.