Search FDA 510(k) Database

7,151 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22009–22032 of 174,061
Cleared Feb 11, 2019
Elitone Device
K183585 · QAJ
Elidah, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 11, 2019
IntraSight
K190078 · DSA
Volcano Corporation
Cardiovascular · 26d
Cleared Feb 11, 2019
Journey II Unicompartmental Knee System
K190085 · HSX
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Feb 08, 2019
SEKURE Acetaminophen L3K Assay
K180835 · LDP
Sekisui Diagnostics P.E.I., Inc.
Toxicology · 315d
Cleared Feb 08, 2019
Keeler TonoCare Tonometer
K181143 · HKX
Keeler Instruments, Inc.
Ophthalmic · 283d
Cleared Feb 08, 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K181317 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 266d
Cleared Feb 08, 2019
Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance...
K181467 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 249d
Cleared Feb 08, 2019
Coala Heart Monitor
K182040 · DXH
Coala Life AB
Cardiovascular · 193d
Cleared Feb 08, 2019
ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ...
K182833 · EIH
The Argen Corporation
Dental · 122d
Cleared Feb 08, 2019
LINK MP Monoblock Hip Prosthesis
K183141 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 87d
Cleared Feb 08, 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint...
K183186 · MOS
Shanghai United Imaging Healthcare...
Radiology · 81d
Cleared Feb 08, 2019
Carestream DRX-1 System with DRX Plus 2530 Detectors
K183245 · MQB
Carestream Health, Inc.
Radiology · 79d
Cleared Feb 08, 2019
Ammonia II
K183517 · JIF
Roche Diagnostics Operations (Rdo)
Chemistry · 52d
Cleared Feb 07, 2019
AcQMap High Resolution Imaging and Mapping System
K181577 · DQK
Acutus Medical, Inc.
Cardiovascular · 237d
Cleared Feb 07, 2019
SafeAir Smoke Evacuator compact
K182224 · FYD
Lina Medical Aps
General Hospital · 175d
Cleared Feb 07, 2019
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
K182259 · FTM
Acell, Inc.
General & Plastic Surgery · 170d
Cleared Feb 07, 2019
ROSA ONE Brain Application
K182417 · HAW
Medtech S.A
Neurology · 155d
Cleared Feb 07, 2019
dpl SpotLite
K183118 · OLP
Led Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Feb 07, 2019
ArcTV Transvaginal Sling System
K183134 · OTN
Urocure, LLC
Gastroenterology & Urology · 86d
Cleared Feb 07, 2019
SonoSite SII Ultrasound System
K183235 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 79d
Cleared Feb 07, 2019
Parcus GFS BTB
K183331 · MBI
Parcus Medical, LLC
Orthopedic · 66d
Cleared Feb 07, 2019
Biomet Headless Compression and Twist-Off Screws
K190035 · HWC
Biomet, Inc.
Orthopedic · 30d
Cleared Feb 06, 2019
CO2 Sampling Line
K181981 · CCK
Tylenol Medical Instruments Co., Ltd.
Anesthesiology · 196d
Cleared Feb 06, 2019
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS...
K182102 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 187d