FDA 510(k) clearances — page 131
clearances on record, most recent first.
Clearances — page 131
13,001–13,100 of 176,479- K222303 — Unistik® Pro
- K222365 — Leltek Ultrasound Imaging System (Model: LU700 Series)
- K222415 — Rexious Spinal Fixation System
- K222470 — 3Dicom MD
- K222968 — Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
- K212493 — KODEX EPD System 1.5.0
- K220190 — The GIRO Growth Modulation System
- K221545 — MectaLIF Anterior Extension
- K221563 — Neurosteer EEG Recorder
- K221783 — SafetiCET Safety Lancet
- K222127 — Soft Palate Elevator
- K213804 — cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
- K222058 — Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
- K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
- K212391 — MCI-Neuro Fixation System
- K213128 — IntraOp VSP Software Device
- K220165 — Enteral Transition Adaptor
- K220273 — Onetouch Non-paraben Lubricant Gel
- K221022 — NextDent Ortho Flex
- K221443 — PureLift Pro Plus
- K221462 — DePuy Reclaim Monobloc Revision Femoral Stem
- K221643 — Hair Removal Device (Model: IPL-D26, IPL-D19)
- K221751 — NuVasive Cohere ALIF System Intervertebral Body Fusion Device
- K221958 — Flex-MI
- K221992 — Electronic Pulse Stimulator
- K222141 — Safety Blood Collection Needle (Without Needle Holder)
- K222199 — Collagen P.I.N. (Percutaneous Induction Needling)
- K222201 — Biological Feedback and Stimulation System
- K222215 — IPD Dental Implant Abutments
- K222270 — HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments
- K222349 — JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
- K222632 — UHR Bipolar Implants, Restoration GAP II Implants
- K223042 — Viz LVO ContaCT
- K213106 — BTI Interna Dental Implant System UnicCa - Prosthetic Components
- K213429 — AccuSert Needle Inserter
- K213466 — Houdini Cross Support Catheter
- K214073 — eWave Monitor
- K220099 — eClinic Stethopod
- K220527 — PADnet Xpress
- K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
- K221740 — SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
- K221947 — Tyber Medical Staple Fixation System (various)
- K221977 — Disposable Surgical Gown (G4003)
- K222361 — AI-Rad Companion (Musculoskeletal)
- K222404 — Evo® sEEG System
- K222547 — Electric nasal aspirator
- K222827 — da Vinci Firefly Imaging System
- K222842 — V-Patch Cardiac Monitor
- K222886 — Mercu 1717V
- K211409 — Proximerge 2 Dental Implant System
- K213742 — Infinity Pro, Logic, Quality, Sprint
- K220992 — Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
- K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
- K221032 — Vascu-Guard Vascular Repair Patch
- K221728 — Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate
- K221795 — STERN FIX Sternal Stabilization System
- K222643 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K222856 — SOMAVAC 100 Sustained Vacuum System
- K222890 — RADIANCE ULTRA 32 4K ZEROWIRE DUO
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.