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

Filters: Cleared only ×
175,820 results
22729–22752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2019
Cepheid Xpert SA Nasal Complete Control Panel
K191168 · PMN
Microbiologics, Inc.
Microbiology · 55d
Cleared Jun 25, 2019
CLARUS
K191194 · QER
Carl Zeiss Meditec, Inc.
Ophthalmic · 53d
Cleared Jun 25, 2019
Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
K191207 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 50d
Cleared Jun 24, 2019
Maxxi Rip Sensor
K171304 · MNR
Neurovirtual USA, Inc.
Anesthesiology · 782d
Cleared Jun 24, 2019
Scooter, Model: R-100
K182411 · INI
Yongkang Dingchang Industry & Trade...
Physical Medicine · 293d
Cleared Jun 24, 2019
FUJIFILM Double Balloon Endoscope EI580BT
K183032 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 235d
Cleared Jun 24, 2019
uWS-CT
K183170 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 220d
Cleared Jun 24, 2019
Intra-Operative Positioning System
K190106 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 153d
Cleared Jun 24, 2019
MMSphere
K190443 · OHS
Galactic Beauty, LLC
General & Plastic Surgery · 119d
Cleared Jun 24, 2019
Oscillometric Blood Pressure Monitor
K190927 · DXN
Rudolf Riester GmbH
Cardiovascular · 76d
Cleared Jun 23, 2019
Orthoss(R)
K190754 · MQV
Geistlich Pharma AG
Orthopedic · 90d
Cleared Jun 22, 2019
ASAHI SASUKE
K182844 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 256d
Cleared Jun 21, 2019
MiiS Horus Scope DPT 100
K181260 · HKX
Medimaging Integrated Solution, Inc...
Ophthalmic · 406d
Cleared Jun 21, 2019
AXTi Titanium Stand-Alone ALIF System
K182139 · OVD
Innovasis, Inc.
Orthopedic · 318d
Cleared Jun 21, 2019
ReliefBand
K182960 · GZJ
Reliefband Technologies, LLC
Neurology · 239d
Cleared Jun 21, 2019
emFieldPro
K182963 · NGX
Zimmer Medizinsysteme GmbH
Physical Medicine · 239d
Cleared Jun 21, 2019
OrthoScan TAU Mini C-Arm
K183220 · OXO
Orthoscan, Inc.
Radiology · 213d
Cleared Jun 21, 2019
EsoCheck CCD Cell Collection Device
K183262 · EOX
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 210d
Cleared Jun 21, 2019
Aqua Medical RF Vapor System
K183595 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 182d
Cleared Jun 21, 2019
The ClearSight finger cuffs
K190130 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 144d
Cleared Jun 21, 2019
Vit Kit- Freeze NX and Vit Kit- Warm NX
K190152 · MQL
Fujifilm Irvine Scientific, Inc.
Obstetrics & Gynecology · 142d
Cleared Jun 21, 2019
LineSider™ Spinal System
K190360 · NKB
Integrity Implants, Inc.
Orthopedic · 126d
Cleared Jun 21, 2019
BRILLIANT EverGlow Flow
K190597 · EBF
Coltene/Whaledent AG
Dental · 106d
Cleared Jun 21, 2019
DePuy Synthes Plates and Screws Portfolio
K190750 · HRS
DePuy Synthes
Orthopedic · 88d