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
33001–33024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 2015
TR BAND Radial Compression Device
K152525 · DXC
Terumo Medical Corporation
Cardiovascular · 68d
Cleared Nov 10, 2015
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
K153058 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 20d
Cleared Nov 10, 2015
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
K153060 · MUH
Rayence Co., Ltd.
Radiology · 20d
Cleared Nov 09, 2015
Divine 9
K150397 · NUC
Carrashield Labs, Inc.
Obstetrics & Gynecology · 264d
Cleared Nov 09, 2015
Patient Contoured Implant-PEEK (PCI-PEEK)
K151382 · GXN
KLS-Martin L.P.
Neurology · 171d
Cleared Nov 09, 2015
Thermofit
K151946 · IYE
Orfit Industries
Radiology · 118d
Cleared Nov 09, 2015
Wrist - Type Fully Automatic Digital Blood Pressure Monitor
K152426 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 75d
Cleared Nov 09, 2015
First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse...
K152551 · DJG
W.H.P.M., Inc.
Toxicology · 62d
Cleared Nov 06, 2015
JDENTALCARE Implant System
K143142 · DZE
Jdentalcare Srl
Dental · 368d
Cleared Nov 06, 2015
MEDLINE SHARPS CONTAINERS
K143693 · MMK
Medline Industries, Inc.
General Hospital · 317d
Cleared Nov 06, 2015
Prevena Incision Management System with Peel & Place Dressing, Prevena...
K150006 · OMP
Kci USA, Inc.
General & Plastic Surgery · 308d
Cleared Nov 06, 2015
CLIP PLUS Disposable Clip Applier,ML
K150259 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 276d
Cleared Nov 06, 2015
CerOX
K150268 · DPW
Or-Nim Medical , Ltd.
Cardiovascular · 275d
Cleared Nov 06, 2015
Breast Pump
K150923 · HGX
Guangzhou Jinxinbao Electronic Co., Ltd.
Obstetrics & Gynecology · 214d
Cleared Nov 06, 2015
InterOss
K151209 · NPM
Sigmagraft, Inc.
Dental · 184d
Cleared Nov 06, 2015
Nox RIP Belts & Cables
K151361 · MNR
Nox Medical Ehf
Anesthesiology · 169d
Cleared Nov 06, 2015
ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
K151609 · GCJ
Nds Surgical Imaging, LLC
General & Plastic Surgery · 144d
Cleared Nov 06, 2015
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
K151713 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 134d
Cleared Nov 06, 2015
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda...
K151759 · OPX
The Binding Site Group , Ltd.
Immunology · 130d
Cleared Nov 06, 2015
Slendertone connect Abs
K151903 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 119d
Cleared Nov 06, 2015
Elation Wireguided Balloon Dilation Catheter
K151925 · FGE
Merit Medical Systems, Inc.
Gastroenterology & Urology · 116d
Cleared Nov 06, 2015
PUR Dental Implant System
K151928 · DZE
Sterngold Dental, LLC
Dental · 115d
Cleared Nov 06, 2015
UTERMOHLEN CRYO PROFESSIONAL
K152203 · GEH
Koninklijke (Royal) Utermohlen
General & Plastic Surgery · 92d
Cleared Nov 06, 2015
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
K152567 · IYN
Ge Healthcare
Radiology · 58d