Search FDA 510(k) Database

6,812 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14377–14400 of 174,061
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
Cleared Sep 21, 2021
Disposable Nitrile Examination Gloves
K211073 · LZA
Foshan Kangkang Biotechnology Co., Ltd.
General Hospital · 162d
Cleared Sep 21, 2021
KEYSTONE PEEK Cage System
K211689 · MAX
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 111d
Cleared Sep 21, 2021
Dayspring Lite
K212287 · JOW
Koya Medical, Inc.
Cardiovascular · 62d
Cleared Sep 21, 2021
T2
K212303 · OAS
Osstem Implant Co., Ltd.
Radiology · 60d
Cleared Sep 21, 2021
GEO Extremity and Ankle Plating System
K212334 · HRS
Gramercy Extremity Orthopedics, LLC
Orthopedic · 56d
Cleared Sep 21, 2021
Flyte
K212655 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 21, 2021
Mariner Pedicle Screw System
K212692 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 27d