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
23089–23112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2019
Reprocessed ViewFlex Xtra ICE Catheter
K182238 · OWQ
Stryker Sustainability Solutions
Cardiovascular · 261d
Cleared May 08, 2019
GlucoLeader Enhance Blood Glucose Monitoring System
K182428 · NBW
Hmd Biomedical, Inc.
Chemistry · 244d
Cleared May 08, 2019
Electrosurgical accessory
K183126 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 176d
Cleared May 08, 2019
SomnoDent Avant
K183443 · LRK
Somnomed, Inc.
Dental · 147d
Cleared May 08, 2019
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic...
K183461 · GBM
Teleflexmedical, Inc.
Gastroenterology & Urology · 145d
Cleared May 08, 2019
UNiD Patient specific 3D printed TLIF cage
K190092 · MAX
Medicrea International SA
Orthopedic · 110d
Cleared May 08, 2019
COLOSSEUM Mesh
K190147 · MQP
Globus Medical, Inc.
Orthopedic · 99d
Cleared May 08, 2019
Gynescope System
K190187 · HEX
Illumigyn , Ltd.
Obstetrics & Gynecology · 96d
Cleared May 08, 2019
Cepheid Xpert CT/NG Control Panel
K190223 · PMN
Microbiologics, Inc.
Microbiology · 92d
Cleared May 08, 2019
KeYi Spinal Fixation System
K190567 · NKB
Beijing Keyi Medical Device...
Orthopedic · 63d
Cleared May 07, 2019
OssBuilder System
K181854 · DZL
Osstem Implant Co., Ltd.
Dental · 300d
Cleared May 07, 2019
Neodent Instruments Kits
K182865 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 208d
Cleared May 07, 2019
SteriCap Mini Needle
K183016 · FMI
Ocujet, LLC
General Hospital · 188d
Cleared May 07, 2019
cobas u 601 urinalysis test system
K183432 · JIL
Roche Diagnostics
Chemistry · 147d
Cleared May 07, 2019
Moore Park Mask
K183512 · BZD
Resmed, Ltd.
Anesthesiology · 140d
Cleared May 07, 2019
Stryker ChestShield Sterilization Tray System
K183701 · KCT
Paragon Medical
General Hospital · 127d
Cleared May 07, 2019
Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl...
K190161 · MLY
Gebauer Company
Physical Medicine · 97d
Cleared May 07, 2019
FUJIFILM Endoscope Model EC-760S-V/L
K190649 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 55d
Cleared May 07, 2019
Scope ProTech
K191011 · OCU
Meditech Endoscopy, Ltd.
Gastroenterology & Urology · 21d
Cleared May 06, 2019
MD-6000P Bladder Scanner
K182460 · IYO
MEDA Co., Ltd.
Radiology · 238d
Cleared May 06, 2019
Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
K190159 · LZC
Showa Best Glove, Inc.
General Hospital · 96d
Cleared May 06, 2019
Capstone Control™ Spinal System
K190165 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 95d
Cleared May 06, 2019
Unity Subcutaneous Delivery System for Remodulin
K190182 · FRN
DEKA Research & Development
General Hospital · 94d
Cleared May 06, 2019
HealthPNX
K190362 · QFM
Zebra Medical Vision, Ltd.
Radiology · 80d