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
16129–16152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2021
Reusable NIBP Cuff
K211747 · DXQ
Shenzhen Coreray Technology Co., Ltd.
Cardiovascular · 108d
Cleared Sep 23, 2021
Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
K211827 · FXX
Zhejiang Lanhine Medical Products, Ltd.
General Hospital · 101d
Cleared Sep 23, 2021
LED PHOTIC System
K211974 · GWE
Micromed S.P.A.
Neurology · 90d
Cleared Sep 23, 2021
Nexta PEEK Hammertoe Correction System
K211996 · HWC
Nextremity Solutions, Inc.
Orthopedic · 87d
Cleared Sep 23, 2021
Synthetic Vinyl Examination Gloves
K212002 · LYZ
Yunnan Huazhiyuan Medical Technology...
General Hospital · 87d
Cleared Sep 23, 2021
JiveX (Model Number / Release: 5.3)
K212321 · LLZ
Visus Health IT GmbH
Radiology · 59d
Cleared Sep 23, 2021
ZIIP+ Device
K212342 · NFO
Ziip, Inc.
Neurology · 57d
Cleared Sep 23, 2021
Identity Imprint Knee Replacement System (including Identity Imprint...
K212411 · JWH
Conformis, Inc.
Orthopedic · 51d
Cleared Sep 23, 2021
Halo One Thin-Walled Guiding Sheath
K212708 · DYB
C.R. Bard, Inc.
Cardiovascular · 28d
Cleared Sep 23, 2021
Standard Bougie, 38 Fr. and Hand Pump
K212728 · KNT
Standard Bariatrics
Gastroenterology & Urology · 27d
Cleared Sep 23, 2021
Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212792 · ODP
Medynus, Inc.
Orthopedic · 22d
Cleared Sep 22, 2021
Electric Wheelchair (XW-LY001)
K200423 · ITI
Yongkang Dingchang Industry & Trade...
Physical Medicine · 580d
Cleared Sep 22, 2021
ACTIVA PRESTO PACK
K210045 · EBF
Pulpdent Corporation
Dental · 257d
Cleared Sep 22, 2021
Mpres Neck Preserving Stem
K210263 · LZO
Medacta International S.A.
Orthopedic · 233d
Cleared Sep 22, 2021
3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties...
K210772 · FXX
Vr Vertical, LLC Dba Xrgo
General Hospital · 191d
Cleared Sep 22, 2021
Banyan USA Surgical Mask Level 3
K211097 · FXX
Banyan USA, LLC
General Hospital · 162d
Cleared Sep 22, 2021
IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System,...
K211805 · MAX
Alphatec Spine, Inc.
Orthopedic · 103d
Cleared Sep 22, 2021
SimpleSENSE Platform
K212160 · DXH
Nanowear, Inc.
Cardiovascular · 72d
Cleared Sep 22, 2021
DB-EZ Bone Void Filler
K212353 · MQV
Dimensional Bioceramics, LLC
Orthopedic · 55d
Cleared Sep 22, 2021
Smylio Invisible Clear Aligners
K212660 · NXC
Smylio, Inc.
Dental · 30d
Cleared Sep 22, 2021
Single Use Guide Sheath Kit-401, K-402
K212667 · EOQ
Olympus Medical Systems Corp.
Anesthesiology · 30d
Cleared Sep 22, 2021
FilmArray Pneumonia Panel
K212727 · QDP
Biofire Diagnostics, LLC
Microbiology · 26d
Cleared Sep 21, 2021
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine,...
K200898 · CIX
Medicon Hellas S.A
Chemistry · 536d
Cleared Sep 21, 2021
Elecsys Troponin T Gen 5
K201441 · MMI
Roche Diagnostics
Chemistry · 477d