Search FDA 510(k) Database

6,814 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14473–14496 of 174,061
Cleared Sep 11, 2021
Surgical face mask
K211296 · FXX
Sunsmed Protective Products , Ltd.
General Hospital · 136d
Cleared Sep 10, 2021
Kinepict Medical Imaging Tool 4.0
K202056 · LLZ
Kinepict Health, Ltd.
Radiology · 413d
Cleared Sep 10, 2021
ClariSIGMAM
K203785 · QIH
Claripi, Inc.
Radiology · 256d
Cleared Sep 10, 2021
AccuFFRangio
K210093 · QHA
ArteryFlow Technology Co., Ltd.
Radiology · 239d
Cleared Sep 10, 2021
AlertWatch:AC
K210160 · MSX
Alertwatch, Inc.
Cardiovascular · 232d
Cleared Sep 10, 2021
Sterile syringe for single use with/without needle
K210227 · FMF
Zhejiang Kangkang Medical-Devices...
General Hospital · 225d
Cleared Sep 10, 2021
s-Clean Pre-Milled Abutment Mini
K210410 · NHA
Dentis Co., Ltd.
Dental · 211d
Cleared Sep 10, 2021
Versana Premier
K210438 · IYN
GE Medical Systems Ultrasound and...
Radiology · 210d
Cleared Sep 10, 2021
JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
K210625 · ODC
Fujifilm Medwork GmbH
Gastroenterology & Urology · 192d
Cleared Sep 10, 2021
EFAI PACS Picture Archiving and Communication System
K211257 · LLZ
Ever Fortune.Ai, Co., Ltd.
Radiology · 137d
Cleared Sep 10, 2021
Iovera System
K211334 · GXH
Pacira Pharmaceuticals, Inc.
Neurology · 130d
Cleared Sep 10, 2021
Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
K211375 · DRF
Boston Scientific Corporation
Cardiovascular · 129d
Cleared Sep 10, 2021
LOGIQ E10
K211488 · IYN
Ge Healthcare
Radiology · 120d
Cleared Sep 10, 2021
Aquilion Exceed LB
K211828 · JAK
Canon Medical Systems Corporation
Radiology · 88d
Cleared Sep 10, 2021
gammaCore Sapphire
K211856 · PKR
Electrocore, Inc.
Neurology · 86d
Cleared Sep 10, 2021
Surgical Mask
K212451 · FXX
Remade USA, LLC
General Hospital · 36d
Cleared Sep 10, 2021
Explorer TO System
K212540 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 29d
Cleared Sep 09, 2021
EPIEN Dental Cleanser
K201785 · KJJ
Epien Medical, Inc.
Dental · 436d
Cleared Sep 09, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385 · OZN
Roche Molecular Systems, Inc.
Microbiology · 212d
Cleared Sep 09, 2021
Curiteva Sacroiliac Joint Fusion System
K210402 · OUR
Curiteva, Inc.
Orthopedic · 211d
Cleared Sep 09, 2021
Rocket Platinum Cured Cathter
K210509 · DWM
Rocket Medical Plc
Gastroenterology & Urology · 199d
Cleared Sep 09, 2021
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
K211242 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 136d
Cleared Sep 09, 2021
Electronic Thermometer (XHF2001, XHF2002)
K211352 · FLL
Putian Hanjiang Huafeng Plastic Co.,...
General Hospital · 129d
Cleared Sep 09, 2021
HERA W9, HERA W10 Diagnostic Ultrasound System
K211824 · IYN
Samsung Medison Co., Ltd.
Radiology · 87d