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
27385–27408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2017
ExactechGPS Total Shoulder Application
K173372 · OLO
Blue Ortho
Orthopedic · 28d
Cleared Nov 22, 2017
Non Contact Infrared Forehead Thermometer
K170662 · FLL
Intrinity Global Limited
General Hospital · 264d
Cleared Nov 22, 2017
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
K170666 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 261d
Cleared Nov 22, 2017
NIOX VERO
K170983 · MXA
Circassia AB
Chemistry · 233d
Cleared Nov 22, 2017
I-Portal Portable Assessment System - Nystagmograph (I-PAS)
K171884 · GWN
Neuro Kinetics, Inc.
Ear, Nose, Throat · 152d
Cleared Nov 22, 2017
CamX Triton HD Proxi Head
K172007 · NTK
Duerr Dental AG
Dental · 142d
Cleared Nov 22, 2017
Vevazz LED
K172111 · OLI
Vevazz, LLC
General & Plastic Surgery · 132d
Cleared Nov 22, 2017
EsoFLIP® ES-310 Balloon Catheter
K172128 · PIE
Crospon, Ltd.
Gastroenterology & Urology · 131d
Cleared Nov 22, 2017
GC85A
K172229 · KPR
Samsung Electronics Co., Ltd.
Radiology · 120d
Cleared Nov 22, 2017
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278 · GBM
Cook Incorporated
Gastroenterology & Urology · 117d
Cleared Nov 22, 2017
DENTCA DENTURE Teeth
K172398 · PZY
Dentca, Inc.
Dental · 106d
Cleared Nov 22, 2017
Velofix™ SA Cervical Cage
K172424 · OVE
U&I Corporation
Orthopedic · 104d
Cleared Nov 22, 2017
OrthAlign Plus System
K172462 · OLO
Orthalign, Inc.
Orthopedic · 100d
Cleared Nov 22, 2017
CereTom Elite
K172539 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 91d
Cleared Nov 22, 2017
GenePOC CDiff
K172569 · OZN
Genepoc, Inc.
Microbiology · 89d
Cleared Nov 22, 2017
BioHorizons Tapered Short Implants
K172576 · DZE
BioHorizons Implant Systems, Inc.
Dental · 86d
Cleared Nov 22, 2017
AIR Anterior Array, AIR Posterior Array
K172695 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 76d
Cleared Nov 22, 2017
Azurion series R1.2
K172822 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 65d
Cleared Nov 22, 2017
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore...
K172859 · PLC
Prosomnous Sleep Technologies
Dental · 63d
Cleared Nov 22, 2017
HemosIL D-Dimer HS 500
K172903 · DAP
Instrumentation Laboratory CO
Hematology · 61d
Cleared Nov 22, 2017
CEDIA Heroin Metabolite (6-AM) Assay
K173183 · DJG
Microgenics Corporation
Toxicology · 51d
Cleared Nov 21, 2017
Ultrasonic scaler
K163414 · ELC
Nanning VV Dental Co., Ltd.
Dental · 351d
Cleared Nov 21, 2017
KLS Martin Individual Patient Solutions
K163579 · JEY
KLS-Martin L.P.
Dental · 336d
Cleared Nov 21, 2017
Dental Low-speed Turbine Handpiece
K170236 · EFB
Guangdong Jinme Medical Technology...
Dental · 300d