FDA 510(k) clearances — page 338
clearances on record, most recent first.
Clearances — page 338
33,701–33,800 of 175,770- K152526 — Elecsys Progesterone III CalSet
- K152545 — DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
- K142887 — SIS Inguinal Hernia Repair Graft
- K143515 — Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
- K150031 — hemoFISH Masterpanel
- K150221 — EPX-4440HD and EPX-4400HD with FICE
- K150694 — 3M Comply Hydrogen Peroxide Indicator Tape 1228
- K151011 — VISERA 4K UHD SYSTEM
- K151952 — Synergy ODM
- K152177 — SonoStik IV Guide Wire Introducer
- K152523 — JBAIDS Influenza A & B Detection Kit
- K140827 — SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
- K142928 — FreeStyle Precision Neo Blood Glucose Monitoring System
- K143245 — GPC Intramedullary Nailing Systems
- K150078 — PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
- K150565 — Supria Whole-body X-ray CT System
- K151079 — Q2 Intravenous Adminstration Sets and Extension Sets
- K151149 — Ready-Fit
- K151280 — MultiScan G-Arm System
- K151849 — Seneka I Polyscrew Pedicle Fixation System
- K152524 — Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
- DEN150002 — EarLens Contact Hearing Device
- K150622 — 3M Comply Hydrogen Peroxide Chemical Indicator 1248
- K150654 — Cholesterol
- K150998 — HEARTWAY Power Mobility Scooter
- K151100 — U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
- K151576 — Neon EEG
- K151579 — MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
- K151761 — SureSigns VS3, SureSigns VS4
- K151777 — Intradermal Adapter
- K152195 — LOGIQ S8
- K152483 — Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
- K152158 — ARIX Ankle System
- K152171 — Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
- K152488 — Onrad Treatment System
- K143479 — Bluefin Interbody System
- K150402 — Endoluminal Occlusion System-EOS
- K150829 — U2 Total Knee System- Additional Sizes
- K150832 — U2 Femoral Component, CR, Porous Coated, Additional Sizes
- K150862 — DePuy Actis Duofox Hip Prosthesis
- K151358 — AZUR CX Detachable 35 Coils
- K151651 — NuVasive X-CORE Mini Cervical Expandable VBR System
- K151809 — Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
- K152132 — X-spine Pedicle Screw System
- K152193 — Renovis Anterior Cervical Plate System
- K152437 — BiowaveHOME Neuromodulation Pain Therapy Device
- K150650 — neon3
- K151151 — U & U Intravascular Administration Set
- K151293 — Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
- K151592 — Gemmed pedicle screw spinal system
- K151786 — Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
- K152003 — iHealth BP3L Wireless Blood Pressure Monitor
- K152064 — Astringedent Clear
- K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
- K152080 — Metacross OTW PTA Balloon Dilatation Catheter
- K152216 — SudoC
- K152281 — Pyrenees Cervical Plate System
- K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
- K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
- K143685 — Hedgehog Cervical Interbody Fusion Device
- K143736 — ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
- K151306 — Solea
- K151637 — UPT Series Medical RO Water System
- K151647 — Uberlube
- K151742 — Contour Next Control Solution
- K152072 — CrossRoads Screw System
- K152317 — Stretta Catheter
- K152379 — iHealth View BP7S Wireless Blood Pressure Wrist Monitor
- K152407 — Infinity Delta, Infinity Delta XL, Infinity Kappa
- K152440 — Sydney IVF PVP
- K150532 — Universal Light Handle Cover, Light Handle Cover
- K150987 — HEARTWAY Power Mobility Scooter, BRIO S19
- K151179 — ZELTIQ CoolSculpting System
- K151951 — Destino Reach
- K152403 — Permanent Sled Bag
- K142349 — TM eCloud ECG Analysis System
- K142557 — Anker Dental Implant System - SB-III, ST and AT series
- K143754 — QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
- K150657 — Phoenix XL Dialysate Meter
- K151195 — OsteoMed IMF Screw
- K151262 — Hyflex Heavy, Hyflex Mono, Hyflex Light
- K151313 — ZelanteDVT Thrombectomy Set
- K151514 — Prestige
- K151564 — Telio CAD Abutment Solutions
- K151678 — Chameleon PTA Balloon Catheter
- K151774 — CARESTREAM Vue Motion
- K151830 — Hummingbird Tympanostomy Tube
- K152218 — AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System
- K152383 — Ceramill Zolid FX
- K152404 — Hi-Torque Command 18 Guide Wire
- K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
- K152469 — ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System
- K142293 — Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
- K143677 — DeVilbiss Intellipap2/DeVilbiss BLUE
- K143696 — Spirit
- K143720 — Dimension Vista MMB Assay
- K143743 — ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
- K150392 — PROPEL device
- K150638 — AF541 SE Full Face Mask
- K150639 — AF541 EE Full Face Mask
Data sourced from openFDA. This site is unofficial and independent of the FDA.