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
16897–16920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2021
Quantum Perfusion Arterial Cannula Graft
K203057 · DWF
Qura S.R.L
Cardiovascular · 265d
Cleared Jun 30, 2021
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
K203717 · GCJ
Fujifilm Corporaton
General & Plastic Surgery · 191d
Cleared Jun 30, 2021
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus...
K210044 · MAX
Spinal Elements, Inc.
Orthopedic · 174d
Cleared Jun 30, 2021
Stryker iBur hubs and cutting accessories
K210377 · HBE
Stryker Corporation
Neurology · 141d
Cleared Jun 30, 2021
LUMINELLE DTx System
K210512 · FAJ
Uvision360, Inc.
Obstetrics & Gynecology · 127d
Cleared Jun 30, 2021
aprevo Transforaminal IBF
K210542 · MAX
Carlsmed, Inc.
Orthopedic · 126d
Cleared Jun 30, 2021
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50...
K210560 · DPS
Philips Medical Systems
Cardiovascular · 125d
Cleared Jun 30, 2021
KardiaMobile 6L
K210753 · DXH
AliveCor, Inc.
Cardiovascular · 107d
Cleared Jun 30, 2021
Metapaste Plus
K210904 · KIF
Meta Biomed Co., Ltd.
Dental · 96d
Cleared Jun 30, 2021
Oral/Enteral Syringe with ENFit connector
K211025 · PNR
Ningbo Tianyi Medical Appliance Co.,...
Gastroenterology & Urology · 85d
Cleared Jun 30, 2021
LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
K211768 · KRO
Waldemar Link GmbH & Co. KG
Orthopedic · 22d
Cleared Jun 29, 2021
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20,...
K203645 · IYN
Supersonic Imagine
Radiology · 197d
Cleared Jun 29, 2021
12MP Color Digital Mammography LCD Monitor CL-S1200
K203733 · PGY
Jvckenwood Corporation
Radiology · 190d
Cleared Jun 29, 2021
Standard Bougie, 38 Fr.
K210437 · KNT
Standard Bariatrics
Gastroenterology & Urology · 137d
Cleared Jun 29, 2021
Nordiwell Surprotect Face Mask
K210445 · FXX
Changzhou Combat Protective Equipment...
General Hospital · 133d
Cleared Jun 29, 2021
RayStation 10.1
K210645 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 118d
Cleared Jun 29, 2021
Smith & Nephew Plates and Screws
K210837 · HRS
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared Jun 29, 2021
STAGE
K210843 · LNH
Spintech, Inc.
Radiology · 99d
Cleared Jun 29, 2021
Synergy
K210954 · OHS
Yrs Group, Inc.
General & Plastic Surgery · 91d
Cleared Jun 29, 2021
Biophotas Celluma RESTORE
K211038 · OAP
Biophotas, Inc.
General & Plastic Surgery · 83d
Cleared Jun 28, 2021
CenterMed Patient Matched Assisted Surgical Planning (ASP) System
K201353 · DZJ
Centermed, Inc.
Dental · 403d
Cleared Jun 28, 2021
ENFit Disposable Enteral Syringe
K203410 · PNR
Shantou Wealy Medical Instrument Co.,Ltd
Gastroenterology & Urology · 221d
Cleared Jun 28, 2021
Diafil & Diafil Capsule
K210421 · EBF
DiaDent Group International
Dental · 137d
Cleared Jun 28, 2021
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K210587 · LZA
Onetexx Sdn Bhd
General Hospital · 122d