Search FDA 510(k) Devices

5,543 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
3001–3024 of 3,347
Cleared Feb 16, 2023
Sterile Aesthetic Cannula and Hypodermic Needle
K223327 · FMI
Shanghai Kindly Enterprise...
General Hospital · 108d
Cleared Feb 16, 2023
PMMA Blocks for Dental Use
K223477 · EBG
Aidite (Qinhuangdao) Technology Co.,...
Dental · 90d
Cleared Feb 16, 2023
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)
K223478 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Feb 16, 2023
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
K223524 · OHT
Morlaser Shenzhen Co., Ltd.
General & Plastic Surgery · 85d
Cleared Feb 16, 2023
CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4
K223733 · DQK
Biosense Webster, Inc.
Cardiovascular · 65d
Cleared Feb 16, 2023
NUVISION™ NAV Ultrasound Catheter
K223766 · OBJ
Biosense Webster, Inc.
Cardiovascular · 63d
Cleared Feb 16, 2023
Sonopet 1Q 3 7cm 1Q Large
K223770 · LFL
Stryker Corporation
General & Plastic Surgery · 63d
Cleared Feb 16, 2023
Vivid S60N, Vivid S70N
K223832 · IYN
Ge Medical System Ultrasound and...
Radiology · 56d
Cleared Feb 16, 2023
Bony Trauma Extremity System (BTES) Screw Range, NX Nail
K230118 · HWC
Field Orthopaedics Pty, Ltd.
Orthopedic · 30d
Cleared Feb 15, 2023
LIGHTSCALPEL LS-4020
K213669 · GEX
Lightscalpel, Inc.
General & Plastic Surgery · 450d
Cleared Feb 15, 2023
Tanning Lamp
K221523 · LEJ
Unilam Co., Ltd.
General & Plastic Surgery · 265d
Cleared Feb 15, 2023
Altis Single Incision Sling System
K221874 · PAH
Coloplast A/S
Gastroenterology & Urology · 232d
Cleared Feb 15, 2023
Verisafe Safety sterile needles
K222271 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 201d
Cleared Feb 15, 2023
ZEUS System
K222389 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 191d
Cleared Feb 15, 2023
Arm Blood Pressure Monitor
K222869 · DXN
Andon Health Co, Ltd.
Cardiovascular · 146d
Cleared Feb 15, 2023
SC HONKYTONK PTCA Balloon Dilatation Catheter
K223022 · LOX
Sino Medical Sciences Technology, Inc.
Cardiovascular · 139d
Cleared Feb 15, 2023
Xpert® FII & FV
K223046 · NPR
Cepheid
Hematology · 139d
Cleared Feb 15, 2023
Versana Essential
K223407 · IYN
GE Medical Systems Ultrasound and...
Radiology · 98d
Cleared Feb 15, 2023
ONE DROP Lancing Device
K223815 · QRK
Stat Medical Devices
General & Plastic Surgery · 57d
Cleared Feb 15, 2023
Cobra Catheter System
K223891 · QEW
Endovascular Engineering
Cardiovascular · 50d
Cleared Feb 15, 2023
ReShape Calibration Tubes
K230131 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 29d
Cleared Feb 15, 2023
Digital Radiography CXDI-CS01
K230175 · MQB
Canon, Inc.
Radiology · 26d
Cleared Feb 14, 2023
Endocem MTA Premixed Regular
K213757 · KIF
Maruchi
Dental · 441d
Cleared Feb 14, 2023
Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device,...
K221468 · MAI
Acuitive Technologies, Inc.
Orthopedic · 270d