Search FDA 510(k) Devices

5,373 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2022–2022 ×
3,212 results
1–24 of 3,212
Cleared Dec 30, 2022
X-ray Flat Panel Detectors (EverestView 4343X)
K223687 · MQB
Careray Digital Medical Technology...
Radiology · 21d
Cleared Dec 30, 2022
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K223616 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 25d
Cleared Dec 30, 2022
ControlSeal Electrode (ELSB)
K223605 · GXY
Coapt
Neurology · 28d
Cleared Dec 30, 2022
DNA Appliance
K222872 · LRK
Vivos Therapeutics, Inc.
Dental · 99d
Cleared Dec 30, 2022
PeekMed web (v1)
K222767 · LLZ
Peek Health, S.A.
Radiology · 108d
Cleared Dec 30, 2022
aprevo® Digital Workflow
K222195 · LLZ
Carlsmed, Inc.
Radiology · 161d
Cleared Dec 30, 2022
Biobeat Platform-2 and BB-613WP Patch
K222010 · DQA
Biobeat Technologies , Ltd.
Cardiovascular · 176d
Cleared Dec 30, 2022
Persyst 15 EEG Review and Analysis Software
K222002 · OMB
Persyst Development Corporation
Neurology · 176d
Cleared Dec 30, 2022
Cyware 4H and Cysart 4H
K221796 · LLZ
Abys Medical
Radiology · 192d
Cleared Dec 30, 2022
Isolator® Linear Pen (MLP1)
K221358 · OCL
AtriCure, Inc.
Cardiovascular · 233d
Cleared Dec 30, 2022
Aesculap AICON Container
K214041 · KCT
Aesculap, Inc.
General Hospital · 372d
Cleared Dec 30, 2022
Fingertip Pulse Oximeter
K213430 · DQA
Shenzhen Witleaf Medical Electronics...
Anesthesiology · 435d
Cleared Dec 30, 2022
CMFlexTM
K213260 · LYC
Dimension Inx Corp.
Dental · 456d
Cleared Dec 30, 2022
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
K210313 · DRF
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 695d
Cleared Dec 29, 2022
CLEAR+BRILLIANT TOUCH® Laser System
K223647 · GEX
Solta Medical, Inc.
General & Plastic Surgery · 23d
Cleared Dec 29, 2022
Reflow System Mini and ReFlow Mini Flusher
K223603 · JXG
Anuncia Medical, Inc.
Neurology · 27d
Cleared Dec 29, 2022
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
K223592 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Dec 29, 2022
Total Bilirubin2
K223324 · CIG
Abbott Ireland Diagnostics Division
Chemistry · 59d
Cleared Dec 29, 2022
BioClean Implant Restorative System
K222984 · NHA
Bioclean Dental, LLC
Dental · 92d
Cleared Dec 29, 2022
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life...
K222528 · KPI
Well-Life Healthcare Limited
Gastroenterology & Urology · 129d
Cleared Dec 29, 2022
SafeR Syringe and SafeR Sting
K221981 · MEG
Roncadelle Operations Srl
General Hospital · 177d
Cleared Dec 29, 2022
Atalante
K221859 · PHL
Wandercraft SAS
Neurology · 185d
Cleared Dec 29, 2022
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE...
K221690 · FAJ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 202d
Cleared Dec 29, 2022
AG100s
K221477 · BSK
Hospitech Respiration , Ltd.
Anesthesiology · 220d