FDA 510(k) clearances — page 294
clearances on record, most recent first.
Clearances — page 294
29,301–29,400 of 175,699- K163161 — Sterile Single-use Syringe with Needle
- K163162 — Sterile Hypodermic Safety Syringes for Single Use
- K163175 — Bel-Cypher Pro
- K163323 — Dolphix® External Fixation System MR Conditional
- K163488 — Flex-Thread Clavicle Pin System
- K170296 — CoreCath 2.7S
- K170539 — Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
- K153600 — Consult Station TS
- K161077 — RnD TE and RnD SE
- K161250 — OC-FLEX Flexible IntraOral Cannula
- K162308 — Noris Medical MBI-2mm Dental Implant System
- K162522 — UltraCath Continuous Nerve block Catheter
- K162562 — OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
- K162868 — Exam Vue PACS
- K162898 — Olecranon Plating System
- K163239 — SMARTmatic
- K163331 — Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist
- K163346 — MAZIC Duro
- K163378 — Monarch Airway Clearance System
- K163569 — Elecsys CMV IgM
- K163586 — Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
- K163655 — Sparkling
- K170501 — CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
- K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
- K161416 — Multi-unit Abutment Plus
- K161705 — U2 Total Knee System E-XPE products
- K161840 — LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
- K162070 — JOINIX CANNULAR SYSTEM
- K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL
- K162313 — NuVasive Next Generation NVM5 System
- K162880 — TIPCAM 1S 3D System
- K163003 — Y3 Proximal Femoral Plate System
- K163082 — 6200 Ultrasound System and 6250 Ultrasound System
- K163201 — KYMCO EQ10D Scooter
- K163230 — NuVasive Modulus XLIF Interbody System
- K163471 — Kalitec Direct InSePtion MIS Fixation System
- K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit
- K170451 — FDX Console (DR-ID300CL) Software
- K170455 — MectaLIF Anterior Stand Alone
- K162415 — Spectra 9Plus
- K162905 — SleepWeaver 3D Nasal Mask
- K163364 — MOJAVE Expandable Interbody System
- K163572 — LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
- K160287 — Rapid Barostat Bag (RBB) Pump and Catheter
- K161598 — NobelZygoma 0°
- K161785 — THD ANOPRESS
- K161880 — NIVR58-T kit
- K162960 — TotalC-Ram
- K163093 — Safety Blood Collection Set
- K163517 — Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
- K163522 — FilmArray Warrior Control Panel M290
- K170127 — HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
- K162429 — ZipE Knotless Tissue Repair and Attachment Devices
- K162654 — mollosil plus
- K162836 — FUJIFILM Surgical System
- K162921 — Navigated Instrument System
- K163039 — ORTHOLOC® 3Di Small Bones Plating
- K163563 — VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL)
- K170030 — NOVATECH TALCAIR
- K170116 — Thermi Injectable RF Electrodes
- K163152 — PROLENE Soft Polypropylene Mesh
- K160815 — Interstitial Needles
- K162509 — Infrared Non-contact Thermometer, Model ACT8100
- K162589 — Adscope 658 Electronic Stethoscope
- K162733 — iFuse Implant System® - iFuse-3D implant
- K162793 — RHYTHMIA HDx Mapping System
- K162935 — Rapid2 Therapy System
- K163376 — Mikro-Cath Pressure Catheter
- K163474 — CAVUX CervicalCage-L SA System
- K163495 — AdvanCE capsule endoscope delivery device
- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K170084 — InterLock Trocar
- K170336 — BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
- K170508 — EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
- K170512 — Altus Spine Titanium Interbody Fusion System
- K161547 — Transem and EchoGen Embryo Transfer Catheters
- K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
- K162412 — Hoggan Scientific® microFET2
- K162506 — PhotoFix Decellularized Bovine Pericardium
- K163118 — FLEX Microwave Ablation System and Accessories
- K163224 — JAZZ SOLO Sensor
- K163247 — 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
- K163286 — ARTIS pheno
- K163604 — SeaSpine® Daytona® Small Stature Spinal System
- K170065 — ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
- K170124 — Level One Hand Plating System
- K170126 — NuVasive® Reline® 4.5-5.0 System
- K170267 — BGM009 Plus Blood Glucose Monitoring System
- K170391 — ANSiStim-PP
- K170528 — Sterispine PS
- K160641 — Solitaire Platinum Revascularization Device, 6x40 mm
- K161681 — Nipro SafeTouch IV Catheter
- K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
- K161898 — Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
- K162394 — CRC-77tHR
- K162804 — Q2 Low Pressure Power Injection Extension Set
- K162890 — BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
- K163054 — DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
- K163307 — Expro Elite Snare, Sympro Elite Snare
- K163409 — Rampart(TM) T Lumbar Interbody Fusion Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.