FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
27865–27888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2017
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical...
K171699 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 50d
Cleared Jul 28, 2017
NovaPACS
K171754 · LLZ
Novarad Corporation
Radiology · 45d
Cleared Jul 28, 2017
Discovery Pico, Discovery Pico Plus
K171945 · GEX
Quanta System Spa
General & Plastic Surgery · 30d
Cleared Jul 28, 2017
VitalBeam
K172013 · IYE
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Jul 27, 2017
SML-OSA2 Appliances
K162816 · LQZ
Selane Products, Inc.
Dental · 294d
Cleared Jul 27, 2017
TIGR Matrix Surgical Mesh
K163005 · OWT
Novus Scientific AB
General & Plastic Surgery · 272d
Cleared Jul 27, 2017
Bunegin-Albin Air Aspiration Set
K163031 · DXE
Cook Incorporated
Cardiovascular · 269d
Cleared Jul 27, 2017
VacLok AT Vacuum Syringe
K163597 · PUR
Merit Medical Systems, Inc.
General Hospital · 218d
Cleared Jul 27, 2017
ARIX Ankle Distal Tibia System
K170313 · HRS
Jeil Medical Corporation
Orthopedic · 176d
Cleared Jul 27, 2017
3M Comply Hydrogen Peroxide Indicator Tape
K170563 · JOJ
3M Company
General Hospital · 150d
Cleared Jul 27, 2017
Fully Automatic Blood Pressure Monitor
K171282 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jul 27, 2017
Nasal Alar SpO2 Sensor
K171423 · DQA
Xhale, Inc.
Anesthesiology · 73d
Cleared Jul 27, 2017
VISCO 360 Viscosurgical System
K171905 · MRH
Sight Sciences, Inc.
Ophthalmic · 31d
Cleared Jul 27, 2017
truFreeze System
K172041 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 21d
Cleared Jul 26, 2017
MagDen Dental Implant System
K162867 · DZE
Shinhung Mst Co., Ltd.
Dental · 286d
Cleared Jul 26, 2017
Orbit Inserter
K163400 · KZH
Ypsomed AG
General Hospital · 233d
Cleared Jul 26, 2017
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
K163536 · PEX
Bruker Daltonik GmbH
Microbiology · 222d
Cleared Jul 26, 2017
wireless thermometer
K170769 · FLL
Ech (Changzhou) Medical Instrument...
General Hospital · 134d
Cleared Jul 26, 2017
HygePLUS Alginate Impression Material
K170812 · ELW
Hygedent, Inc.
Dental · 131d
Cleared Jul 26, 2017
BiopSee, Mobile US
K170841 · LLZ
Medcom GmbH
Radiology · 127d
Cleared Jul 26, 2017
NHAC 16
K171515 · MOS
Lmt Medical Systems GmbH
Radiology · 63d
Cleared Jul 26, 2017
Hydrocleanse Antimicrobial Skin and Wound Care Solution
K171727 · FRO
Sonoma Pharmaceuticals
General & Plastic Surgery · 44d
Cleared Jul 25, 2017
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
K162312 · LZA
Shen Wei (Usa), Inc.
General Hospital · 341d
Cleared Jul 25, 2017
PHMB Antimicrobial Foam Wound Dressing
K163062 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 265d