Search FDA 510(k) Database

6,745 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
12865–12888 of 174,061
Cleared Mar 23, 2022
Total Immunoglobulin E (IgE)
K220178 · DGC
Beckman Coulter, Inc.
Immunology · 61d
Cleared Mar 23, 2022
COPAL exchange G hip spacer
K220492 · KWY
Heraeus Medical GmbH
Orthopedic · 29d
Cleared Mar 23, 2022
Pounce Thrombectomy System
K220501 · QEW
Surmodics,Inc.
Cardiovascular · 29d
Cleared Mar 22, 2022
Athelas Home
K200828 · GKZ
Athelas, Inc.
Hematology · 722d
Cleared Mar 22, 2022
Creatinine2
K210452 · CGX
Abbott Ireland Diagnostics Division
Chemistry · 399d
Cleared Mar 22, 2022
PLEXR PLUS
K210693 · GEI
Gmv S.R.L.
General & Plastic Surgery · 379d
Cleared Mar 22, 2022
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
K212960 · IYN
Canon Medical Systems Corporation
Radiology · 187d
Cleared Mar 22, 2022
AMSafe Pre-Filled Normal Saline Flush Syringe
K213522 · NGT
Amsino International, Inc.
General Hospital · 139d
Cleared Mar 22, 2022
Powder Free Blue Nitrile Examination Gloves
K213678 · LZA
Lienteh Technology Sdn Bhd
General Hospital · 120d
Cleared Mar 22, 2022
LOGIQ P10, LOGIQ P9, LOGIQ P8
K214039 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Mar 22, 2022
Shani Darden LED light therapy mask
K214103 · OLP
Harpar Grace International
General & Plastic Surgery · 83d
Cleared Mar 22, 2022
StealthFix Intraosseous Fixation System
K220181 · JDR
Nextremity Solutions, Inc.
Orthopedic · 60d
Cleared Mar 22, 2022
Medline UNITE IM Fibula Implant
K220511 · HWC
Medline Industries, LP
Orthopedic · 28d
Cleared Mar 21, 2022
WatchPAT200U (WP200U)
K203839 · MNR
Itamar Medical , Ltd.
Anesthesiology · 446d
Cleared Mar 21, 2022
Multi-Functional Electrosurgical Knife
K212999 · KNS
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology · 182d
Cleared Mar 21, 2022
Solus Gold Embolization Device
K213200 · KRD
Artio Medical, Inc.
Cardiovascular · 173d
Cleared Mar 21, 2022
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball...
K213246 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 172d
Cleared Mar 21, 2022
BriefCase
K213721 · QAS
Aidoc Medical , Ltd.
Radiology · 117d
Cleared Mar 21, 2022
AFFINITY Proximal Tibia System
K220199 · HRS
Techfit Digital Surgery, Inc.
Orthopedic · 56d
Cleared Mar 18, 2022
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3...
K203237 · FYA
Dukal Corporation
General Hospital · 500d
Cleared Mar 18, 2022
Albumin BCP2
K203530 · CJW
Abbott Ireland Diagnostics Division
Chemistry · 471d
Cleared Mar 18, 2022
Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)
K210171 · FLL
Sichuan Youkede Medical Equipment...
General Hospital · 420d
Cleared Mar 18, 2022
LYMA Laser
K210823 · OHS
Lyma Life , Ltd.
General & Plastic Surgery · 364d
Cleared Mar 18, 2022
ARISTE AB Mesh
K211132 · FTL
Ariste Medical, LLC
General & Plastic Surgery · 336d