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
19009–19032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2020
DigitalDiagnost C90
K202564 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 26d
Cleared Sep 30, 2020
Wiygul Catheter
K202566 · EZD
Big Blue Biotech, Inc.
Gastroenterology & Urology · 26d
Cleared Sep 29, 2020
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50...
K191738 · DPS
Philips Medical Systems
Cardiovascular · 459d
Cleared Sep 29, 2020
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal...
K193131 · BSP
Becton, Dickinson and Company
Anesthesiology · 322d
Cleared Sep 29, 2020
Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
K193401 · DZE
Altatec GmbH
Dental · 298d
Cleared Sep 29, 2020
Dual Cure Resin Cement
K201790 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 91d
Cleared Sep 29, 2020
Cadwell Apollo System
K201819 · GWQ
Cadwell Industries, Inc.
Neurology · 90d
Cleared Sep 29, 2020
Cefaly Dual
K201895 · PCC
Cefaly Technology
Neurology · 83d
Cleared Sep 29, 2020
LVivo Seamless
K202546 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 27d
Cleared Sep 28, 2020
da Vinci SP Surgical System
K192717 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 367d
Cleared Sep 28, 2020
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
K193299 · LON
bioMerieux, Inc.
Microbiology · 306d
Cleared Sep 28, 2020
Enteral Feeding Syringes with ENfit connector (Model: 10 ml
K200557 · PNR
Jiangsu Shenli Medical Production...
Gastroenterology & Urology · 209d
Cleared Sep 28, 2020
Electrosurgical Generator
K201221 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 145d
Cleared Sep 28, 2020
RIST Radial Access Catheter
K201682 · QJP
Rist Neurovascular, Inc.
Neurology · 98d
Cleared Sep 28, 2020
Transcend
K201795 · EBF
Ultradent Product, Inc.
Dental · 90d
Cleared Sep 28, 2020
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical...
K201814 · OYE
Becton, Dickinson and Company
Immunology · 89d
Cleared Sep 28, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide...
K202543 · DQX
Volcano Corporation
Cardiovascular · 26d
Cleared Sep 28, 2020
Eon Aligner
K202685 · NXC
Eon Dental Jordan, LLC
Dental · 13d
Cleared Sep 27, 2020
Portable Mesh Nebulizer
K182906 · CAF
Feellife Health, Inc.
Anesthesiology · 711d
Cleared Sep 25, 2020
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230,...
K191982 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 428d
Cleared Sep 25, 2020
Distal Centralizers
K193546 · JDG
Biomet, Inc.
Orthopedic · 280d
Cleared Sep 25, 2020
Restrata®
K193583 · QSZ
Acera Surgical, Inc.
General & Plastic Surgery · 277d
Cleared Sep 25, 2020
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · LZH
Amsino International, Inc.
General Hospital · 259d
Cleared Sep 25, 2020
Breezing Med
K200076 · BZL
Tf Health Co.
Anesthesiology · 255d