Search FDA 510(k) Database

6,718 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
12433–12456 of 174,061
Cleared May 11, 2022
Plus Medical Cover Gown
K213177 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 225d
Cleared May 11, 2022
Wireless EEG System
K213299 · OLT
Pascall Systems, Inc.
Neurology · 222d
Cleared May 11, 2022
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K220250 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 100d
Cleared May 11, 2022
Versana Balance
K220446 · IYN
GE Medical Systems Ultrasound and...
Radiology · 84d
Cleared May 11, 2022
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K220587 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 71d
Cleared May 11, 2022
Disposable Barrier Sleeves
K220662 · PEM
Premium Plus (Dongguan) Limited
Dental · 65d
Cleared May 10, 2022
BD CTGCTV2
K210585 · QEP
Becton, Dickinson and Company
Microbiology · 438d
Cleared May 10, 2022
Overjet Caries Assist
K212519 · MYN
Overjet, Inc.
Radiology · 273d
Cleared May 10, 2022
Needle Free Connector
K213004 · FPA
Medcaptain Life Science Co., Ltd.
General Hospital · 232d
Cleared May 10, 2022
Dental diode laser
K214008 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 139d
Cleared May 10, 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220427 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220428 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
K220711 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 60d
Cleared May 10, 2022
inHEART MODELS
K220727 · LLZ
Inheart, Sas
Radiology · 57d
Cleared May 10, 2022
Identity Imprint Knee Replacement System (including Identity Imprint...
K221059 · JWH
Conformis, Inc.
Orthopedic · 29d
Cleared May 10, 2022
RadiForce MX243W
K221136 · PGY
Eizo Corporation
Radiology · 21d
Cleared May 09, 2022
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
K203429 · NJR
Cepheid
Microbiology · 535d
Cleared May 09, 2022
Immunalysis Tapentadol Urine HEIA
K203527 · DJG
Lmmunalysis Corporation
Toxicology · 523d
Cleared May 09, 2022
Sight OLO
K211840 · GKZ
S.D. Sight Diagnostics , Ltd.
Hematology · 329d
Cleared May 09, 2022
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy...
K213022 · EBW
Cefla S.C.
Dental · 231d
Cleared May 09, 2022
Compass BDS Biliary Stent
K213946 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 143d
Cleared May 09, 2022
VersaCross Connect Transseptal Dilator
K220414 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 84d
Cleared May 06, 2022
IWL2020 Blood Glucose Monitoring System
K203711 · NBW
Roche Diabetes Care, Inc.
Chemistry · 501d
Cleared May 06, 2022
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon /...
K211021 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 396d