FDA 510(k) clearances — page 346
clearances on record, most recent first.
Clearances — page 346
34,501–34,600 of 176,542- 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 (3 models)
- 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
- K151095 — Circumplast Circumcision Device
- K151189 — Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
- K151302 — Clinpro Varnish
- K151392 — Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
- K151446 — Recovr Rehabilitation System
- K151518 — BRUSH&BOND PLUS
- K151684 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
- K151728 — CoStorSol plus G
- K151979 — STARband, STARlight
- K152161 — Thoratec CentriMag Return (Arterial) Cannula Kit
- K152190 — Thoratec CentriMag Drainage (Venous) Cannula Kit
- K152316 — iLab Ultrasound Imaging System
- K152335 — Export Advance Aspiration Catheter
- K152393 — Eclipse Treatment Planning System
- K143640 — KSEA CMOS Camera System (C-cam)
- K150765 — LDR Spine ROI-C Cervical Cage System
- K150958 — LifePearl Microshperes
- K150965 — LeForte System II
- K151071 — SmartLinx Vitals Plus Patient Monitoring System
- K151188 — BodyGuardian Remote Monitoring System
- K151471 — Radifocus Glidewire Endoscopic Wire
- K151522 — DEFENDO Bronchoscopy Suction Valve
- K151727 — Everest Spinal System
- K152031 — New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
- K152098 — ODALYS Pedicle Screw System
- K152131 — Reliance Spinal Screw System
- K152328 — FreeStyle InsuLinx Blood Glucose Monotioring System
- K142530 — Partial Knee Application (PKA)
Data sourced from openFDA. This site is unofficial and independent of the FDA.