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
15889–15912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2021
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators...
K212193 · FRC
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 22, 2021
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
K212198 · FRG
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 22, 2021
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
K212200 · MLR
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 22, 2021
UroLift System Rigid Retrieval Kit Sterilization Tray
K212396 · KCT
Neotract, Inc.
General Hospital · 81d
Cleared CT Oct 22, 2021
Aveli
K212399 · OUP
Nc8, Inc.
General & Plastic Surgery · 81d
Cleared CT Oct 22, 2021
IRNF App
K212516 · QDB
Apple, Inc.
Cardiovascular · 73d
Cleared Oct 22, 2021
Neuromark System
K212666 · GEI
Neurent Medical
Ear, Nose, Throat · 60d
Cleared Oct 21, 2021
Legend Pro DMA
K200545 · NGX
Pollogen, Ltd.
Neurology · 597d
Cleared Oct 21, 2021
XO Cross Support Catheter
K210322 · DQY
Transit Scientific, LLC
Cardiovascular · 259d
Cleared Oct 21, 2021
PENTAX Medical Video Bronchoscope EB11-J10
K210928 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 206d
Cleared Oct 21, 2021
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
K211171 · CCK
GE Healthcare Finland Oy
Anesthesiology · 185d
Cleared Oct 21, 2021
Belun Ring BLR-100X
K211407 · DQA
Belun Technology Company Limited
Anesthesiology · 168d
Cleared Oct 21, 2021
GR Splint Resin System
K211415 · MQC
Pro3dure Medical GmbH
Dental · 168d
Cleared Oct 21, 2021
Portable Scalp Cooling System
K211526 · PMC
Cooler Heads Care, Inc.
General & Plastic Surgery · 157d
Cleared Oct 21, 2021
DEKA LipoAI
K212270 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 93d
Cleared Oct 21, 2021
Medical Examination Gloves
K212311 · LZA
Guangzhou Junda Gloves Co., Ltd.
General Hospital · 90d
Cleared Oct 21, 2021
IPL Hair Removal Device
K212314 · OHT
Zhongshan Bisen Plastic Electronic...
General & Plastic Surgery · 90d
Cleared Oct 21, 2021
Tenax Laser Resistant Endotracheal Tube
K213028 · BTR
Bryan Medical, Inc.
Anesthesiology · 30d
Cleared Oct 21, 2021
Treace Medical Concepts (TMC) Screw Fixation System
K213036 · HWC
Treace Medical Concepts, Inc.
Orthopedic · 30d
Cleared Oct 21, 2021
Orthoscan Tau Mini C-Arm
K213113 · OXO
Orthoscan, Inc.
Radiology · 24d
Cleared Oct 20, 2021
Piccolo Potassium Test System
K200865 · MZV
Abaxis, Inc.
Chemistry · 567d
Cleared Oct 20, 2021
Multi-unit Abutment, Multi-unit Angled Abutment
K203808 · NHA
Megagen Implant Co., Ltd.
Dental · 296d
Cleared Oct 20, 2021
PENTAX Medical Video Upper GI Scopes EG17-J10
K210177 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 271d
Cleared Oct 20, 2021
InTray GC
K210511 · JTY
Biomed Diagnostics Incorporated
Microbiology · 239d