FDA 510(k) clearances — page 124
clearances on record, most recent first.
Clearances — page 124
12,301–12,400 of 176,479- K223405 — Access Testosterone
- K223429 — Contour Knee
- K223474 — PathLoc-TA Expandable Lumbar Cage System
- K223480 — Medipoint Blood Lancets
- K223502 — MR Diffusion Perfusion Mismatch V1.0
- K223746 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
- K223748 — Nitrile Exam Gloves (Chemotherapy Drug Tested)
- K221774 — Garmin ECG App
- K221873 — NeoGen PSR System
- K222011 — HandX Instrument - Monopolar Spatula
- K222150 — PreXion3D Expedition
- K222458 — AIBOLIT 3D+
- K222830 — Rainbow 360
- K222976 — MU System
- K223363 — MAMMOVISTA B.smart (VB70)
- K223644 — Neuronaute with IceCap 2 & IceCap 2 Small
- K223731 — NuVasive Modulus-C Interbody System
- K223782 — Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
- K191111 — DD Solid Connect® CAD/CAM Abutments
- K221278 — Transducer Probe Cover
- K222181 — Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
- K223000 — Artix BG
- K223181 — NuVasive Reline System
- K223295 — Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
- K223465 — RadianceTx Radionuclide Brachytherapy Source
- K223719 — Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
- K223738 — Alpha Control Liner System (ACLS)
- K223764 — INFINITY OCT System
- K223931 — Dexcom G6 Continuous Glucose Monitoring (CGM) System
- K211047 — CoCr Head
- K221090 — Metal Cannulated Screw
- K222115 — ISAAC Neurovascular Navigation Catheter
- K222799 — Haymaker® Screw System
- K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV
- K222711 — HS186B Scooter
- K222787 — Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P
- K222789 — VADER® Pedicle System, G21 Cement
- K223336 — Vitrea Software Package, VSTP-002A
- K223789 — 21HQ513D
- K203380 — Disposable Surgical Face Mask
- K211812 — BLUEDIAMOND IMPLANT, Abutment Screw
- K213423 — T3 Platform software
- K221260 — CSF-3
- K222296 — ARTICUL/EZE Ceramic Heads
- K222577 — TECHFIT Diagnostic Models
- K223200 — Curiteva Navigation System
- K223412 — LumiVy Lumbar IBF System
- K223675 — WatchPAT ONE (WP1)
- K223749 — U by Kotex® Click® Unscented Menstrual Tampons
- K213198 — Ax-Surgi Surgical Hemostat
- K221149 — U-Motion II Acetabular System-Extension line
- K221181 — Treace Medical Concepts (TMC) Plating System
- K221266 — Cervical Spine Truss System (CSTS) Interbody Fusion Device
- K222834 — Safety Push Button Blood Collection Set
- K223650 — REMEDY Stemmed Knee Spacer
- K223671 — CONDUIT LLIF Straight Inserters
- K213263 — OnyxCeph
- K221125 — SilentCloud
- K221379 — Steriking LT-Blueline Pouches with Tyvek
- K221693 — Elecsys Anti-HCV II (08837031190)
- K222045 — Wearable Breast Pump (Model S1DW)
- K222182 — Radial Artery Compression Tourniquets
- K222221 — DEKA HELIX
- K222483 — Surgical Face Mask
- K222907 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
- K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
- K223685 — SmoothCool HR System
- K220847 — AETOS Shoulder System
- K222809 — Medical Disposable Face Masks
- K223378 — 3.0T 16ch AIR AA
- K223775 — EZ-STIK Electrodes
- K210313 — EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
- K213260 — CMFlexTM
- K213430 — Fingertip Pulse Oximeter
- K214041 — Aesculap AICON Container
- K221358 — Isolator® Linear Pen (MLP1) +4 more
- K221796 — Cyware 4H and Cysart 4H
- K222002 — Persyst 15 EEG Review and Analysis Software
- K222010 — Biobeat Platform-2 and BB-613WP Patch
- K222195 — aprevo® Digital Workflow
- K222767 — PeekMed web (v1)
- K222872 — DNA Appliance
- K223605 — ControlSeal Electrode (ELSB)
- K223616 — Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
- K223687 — X-ray Flat Panel Detectors (EverestView 4343X)
- K211557 — EndoPATx
- K211619 — Multi-Parameter Patient Monitor
- K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
- K221333 — Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
- K221477 — AG100s
- K221690 — OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
- K221859 — Atalante
- K221981 — SafeR Syringe and SafeR Sting
- K222528 — Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
- K222984 — BioClean Implant Restorative System
- K223324 — Total Bilirubin2
- K223592 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- K223603 — Reflow System Mini and ReFlow Mini Flusher
- K223647 — CLEAR+BRILLIANT TOUCH® Laser System
Data sourced from openFDA. This site is unofficial and independent of the FDA.