FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
16489–16512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2021
TruSPECT Radiological Image Processing Station
K212230 · LLZ
Spectrum Dynamics Medical, Ltd.
Radiology · 31d
Cleared Aug 14, 2021
I.V. Administration Set
K210381 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 186d
Cleared Aug 13, 2021
MEGA-TMS
K192823 · GWF
Soterix Medical, Inc.
Neurology · 681d
Cleared Aug 13, 2021
Clearblue® Early Digital Pregnancy Test
K200913 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 494d
Cleared Aug 13, 2021
Insignis Subcutaneous Needle Sets
K202279 · FPA
Innovative Health Sciences, LLC
General Hospital · 367d
Cleared Aug 13, 2021
Nisus Touch Negative Pressure Wound Therapy Pump
K203693 · OMP
Cork Medical Products, LLC
General & Plastic Surgery · 238d
Cleared Aug 13, 2021
Tyber Medical Anatomical Plating System
K203817 · HRS
Tyber Medical, LLC
Orthopedic · 227d
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