FDA 510(k) clearances — page 123
clearances on record, most recent first.
Clearances — page 123
12,201–12,300 of 175,620- DEN220024 — ScanNav Anatomy Peripheral Nerve Block
- K203549 — Nova Primary Glucose Analyzer System
- K213123 — EVOS Wrist Spanning Plate
- K213978 — TELIGEN System
- K221072 — TRUEdraw Lancing Device, Mini Lancing Device
- K221321 — MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
- K221632 — Spine CAMP
- K221986 — XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
- K222167 — E-Z Chek Chlorine Residual Test Strips (K100-0101B)
- K222203 — DualXSLIM(R) T/PLIF
- K222298 — Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
- K222572 — FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System
- K222657 — MEBO Wound Dressing
- K222721 — Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
- K211785 — CASSATT SIJ Fixation System
- K212746 — ATTUNE Revision Cones
- K221014 — Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
- K221175 — Multi-Lancet Device 2, ReliOn Premier Lancing Device
- K221308 — Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
- K221372 — YUWELL Electronic Blood Pressure Monitor
- K221936 — Standalone ALIF Interbody Fusion System
- K222074 — Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves
- K222209 — AcQMap High Resolution Imaging and Mapping System
- K222495 — Mobility Scooter, Model: W3331F
- K222566 — Zimmer Persona Personalized Knee System
- K222793 — WavelinQ Generator
- K222855 — Digital Radiography CXDI-Pro, Digital Radiography D1
- K213049 — STIMPOD NMS450 Nerve Stimulator
- K221574 — LUDWIG Electrosurgical Device
- K221979 — Pulse Oximeter (Model C101A2, C101B1, C101A3)
- K222791 — SafeBreak Vascular
- K222276 — CONDUIT Cages; FIBERGRAFT BG Putty
- DEN210027 — The Cooral System
- K213183 — Safety Insulin Pen Needles
- K213748 — CoreLevee
- K213857 — HeartFlow Analysis
- K214054 — TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
- K220318 — PAL Infiltration System
- K220914 — Tornier Perform Humeral System Fracture
- K220994 — Shoulder PacemakerTM
- K221093 — X-CUBE 70, X-CUBE 90
- K221172 — FOCUS Interbody System
- K221305 — AI-Rad Companion Organs RT
- K221447 — Southern Anterior Screw Fixated Cage (SASCA)
- K221501 — syngo.via View&GO
- K221504 — BD Surgiphor Antimicrobial Irrigation System
- K221840 — Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
- K221858 — ZSFab Lumbar Interbody System
- K221886 — Sublime Microcatheter
- K222284 — Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
- K222407 — 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
- K222537 — IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
- K222662 — Vitrea CT Cardiac Analysis
- K222797 — X-Pac Expandable Lumbar Cage System
- K211321 — Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)
- K211427 — CREOKORREKT Aligners
- K212702 — IM/ST Fixture System
- K213396 — SPIFE A1AT kit
- K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters
- K220805 — VITEK 2 AST-Gram Positive Cefoxitin Screen
- K220853 — PicoWay Laser System
- K220857 — X-CUBE 50, X-CUBE 60
- K221770 — Fiber Laser Treatment System
- K221857 — Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201
- K221989 — The Oligio
- K222081 — ID-510 iRestore Elite
- K222087 — SCIg60 Infusion System
- K222113 — Abiomed 14Fr Low Profile Introducer Set
- K222448 — UNITY Sacroiliac Joint Fixation System
- K222473 — EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods
- K222763 — Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
- K203638 — AT-Patch ECG Analysis System
- K211872 — PiezoImplant System
- K213120 — OW100S (model OW100S-US)
- K220102 — MOST-T Autoclave
- K220227 — Auto Folding Scooter, S21F
- K220911 — Elecsys CMV IgG
- K220923 — Elecsys HSV-1 IgG (08948844160)
- K220924 — Elecsys HSV-2 IgG (08948887160)
- K221263 — Aqua Naina Plus Sterile Saline Solution
- K221510 — TrusFIL-Flow Flowable Composite Restorative
- K221576 — Ameda Pearl Electric Breast Pump
- K221712 — Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
- K221913 — Arm Blood Pressure Monitor
- K222064 — The Alma Soprano Titanium
- K222068 — Durex Penck III Regular
- K214116 — AAMI4 Isolation Gown
- K220169 — SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)
- K221830 — Apyx One Console
- K221951 — Branchor Balloon Guide Catheter
- K222079 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- K222157 — ECHO Photocoagulator
- K222335 — Surgical Mask
- K222432 — IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
- K222435 — Renamel® Microhybrid ;Renamel® Flowable Microhybrid
- K222744 — Sol-M Luer Lock Syringe
- K223008 — Disposable Vinyl Examination Gloves
- K202163 — Mico One Orthodontic Screw
- K213061 — SuperCheck Pro Blood Glucose Monitoring System
- K213610 — Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps
Data sourced from openFDA. This site is unofficial and independent of the FDA.