Search FDA 510(k) Database

6,827 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14737–14760 of 174,061
Cleared Aug 13, 2021
Neodent Implant System - Zirconia Implant System
K210336 · DZE
Jjgc Industria E Comercio DE...
Dental · 189d
Cleared Aug 13, 2021
Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103,...
K210671 · DXN
Weony (Shenzhen) Technology Co., Ltd.
Cardiovascular · 161d
Cleared Aug 13, 2021
VITROS Chemistry Products PHBR Slides
K210858 · DLZ
Ortho-Clinical Diagnostics, Inc.
Toxicology · 143d
Cleared Aug 13, 2021
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K210958 · CGA
Abbott Point of Care, Inc.
Chemistry · 135d
Cleared Aug 13, 2021
NFLK-2501 Portable X-ray Unit
K211383 · IZL
Neuf, Inc.
Radiology · 101d
Cleared Aug 13, 2021
Every Cycle Reusable Tampon Applicator
K211519 · HEB
Cycle, LLC
Obstetrics & Gynecology · 88d
Cleared Aug 13, 2021
Pitch-Patchs
K211563 · FTL
Xiros, Ltd.
General & Plastic Surgery · 85d
Cleared Aug 13, 2021
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575 · LZG
Insulet Corporation
Chemistry · 84d
Cleared Aug 13, 2021
Caretaker Platform, VitalStream Platform, CT5
K211588 · DXN
Caretaker Medical
Cardiovascular · 81d
Cleared Aug 13, 2021
ARCO FP-S
K211777 · OWB
A.T.S. Applicazione Tecnologie...
Radiology · 65d
Cleared Aug 13, 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211860 · LZA
Anhui Powerguard Technology Co., Ltd.
General Hospital · 58d
Cleared Aug 13, 2021
EMM Ultrasonic Transducer Cover
K211969 · ITX
Exact Medical Manufacturing
Radiology · 50d
Cleared Aug 13, 2021
Jot Dx Insertable Cardiac Monitor
K212206 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 29d
Cleared Aug 13, 2021
WATCHMAN FXD Curve Access System
K212228 · DQY
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Aug 13, 2021
White Endoseal MTA
K212229 · KIF
Maruchi
Dental · 28d
Cleared Aug 12, 2021
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
K201630 · DJG
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 422d
Cleared Aug 12, 2021
Crosser iQ CTO Recanalization System
K203363 · PDU
C.R. Bard, Inc.
Cardiovascular · 269d
Cleared Aug 12, 2021
First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First...
K210327 · QBF
W.H.P.M., Inc.
Toxicology · 189d
Cleared Aug 12, 2021
Disposable Surgical Gown
K210510 · FYA
Shandong Zhushi Pharmaceutical Group...
General Hospital · 171d
Cleared Aug 12, 2021
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
K210661 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 161d
Cleared Aug 12, 2021
Excelsius3D
K210912 · OWB
Globus Medical, Inc.
Radiology · 136d
Cleared Aug 12, 2021
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices,...
K210946 · KNW
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 135d
Cleared Aug 12, 2021
InferRead CT Stroke.AI
K211179 · QAS
Infervision Medical Technology Co., Ltd.
Radiology · 114d
Cleared Aug 12, 2021
Prase-C Anterior Cervical Plate System
K211205 · KWQ
Gbs Commonwealth Co., Ltd.
Orthopedic · 112d