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
21865–21888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2019
Halyard ONE-STEP* Sterilization Wrap
K192147 · FRG
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 63d
Cleared Oct 10, 2019
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K192210 · FLL
Fiab Spa
General Hospital · 57d
Cleared Oct 10, 2019
DigiFix Sterile Kit
K192465 · JEC
Virak Orthopedics, LLC
Orthopedic · 31d
Cleared Oct 10, 2019
VERA
K192474 · LXJ
Reflexion Health, Inc.
Physical Medicine · 30d
Cleared Oct 10, 2019
Spine Wave Navigated Instruments
K192526 · OLO
Spine Wave, Inc.
Orthopedic · 27d
Cleared Oct 09, 2019
AnyRidge Octa 1 Implant System
K182448 · DZE
Megagen Implant Co., Ltd.
Dental · 397d
Cleared Oct 09, 2019
Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
K190314 · IYO
Mednovel Technology, Ltd.
Radiology · 238d
Cleared Oct 09, 2019
Pediatric Nailing PlatformFemur
K190321 · HSB
OrthoPediatrics Corp.
Orthopedic · 238d
Cleared Oct 09, 2019
SolidAIRity III Airway Stabilization System
K190630 · BTR
Securisyn Medical, LLC
Anesthesiology · 211d
Cleared Oct 09, 2019
Nipro Syringe
K191359 · FMF
Nipro Medical Corporation
General Hospital · 141d
Cleared Oct 09, 2019
Visalys Restorative Primer
K191523 · KLE
Kettenbach GmbH & Co. KG
Dental · 121d
Cleared Oct 09, 2019
Arcadia Balloon Catheter
K191596 · HRX
Merit Medical Systems, Inc.
Orthopedic · 114d
Cleared Oct 09, 2019
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
K191687 · DQX
Phenox Limited
Neurology · 107d
Cleared Oct 09, 2019
Parcus Synd-EZ Ti
K191783 · MBI
Parcus Medical, LLC
Orthopedic · 98d
Cleared CT Oct 09, 2019
The Cellfina System
K192185 · OUP
Ulthera, Inc.
General & Plastic Surgery · 58d
Cleared Oct 09, 2019
DynaCAD
K192200 · LLZ
Invivo Corporation
Radiology · 57d
Cleared Oct 09, 2019
CORNICE Cervical Spacer System
K192208 · ODP
Legend Spine Technologies
Orthopedic · 56d
Cleared Oct 08, 2019
Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar...
K182773 · GEI
Faulhaber Pinzetten Ohg
General & Plastic Surgery · 372d
Cleared Oct 08, 2019
ScopeSeal Duodenoscope Protective Device
K183171 · ODB
Gi Scientific, LLC
Gastroenterology & Urology · 326d
Cleared Oct 08, 2019
Advanced Intermezzo Implant System
K191127 · DZE
Megagen Implant Co., Ltd.
Dental · 162d
Cleared Oct 08, 2019
KATANA Cleaner, KATANA Cleaner (Trial)
K191133 · PME
Kuraray Noritake Dental, Inc.
Dental · 162d
Cleared Oct 08, 2019
Bodycad Unicompartmental Knee System
K191150 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 160d
Cleared CT Oct 08, 2019
TSolution One Total Knee Application
K191369 · OLO
THINK Surgical, Inc.
Orthopedic · 139d
Cleared Oct 08, 2019
Barrier Sleeves
K191448 · PEM
Ivoclar Vivadent, AG
Dental · 130d