Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
33601–33624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared CT Nov 06, 2015
Ablatherm Integrated Imaging
K153023 · PLP
Edap Technomed, Inc.
Gastroenterology & Urology · 22d
Cleared Nov 05, 2015
SnoreSounds
K150102 · MNR
Appian Medical, Inc.
Anesthesiology · 289d
Cleared Nov 05, 2015
Equashield Closed System drug Transfer Device (CSTD)
K150219 · ONB
Equashield Medical , Ltd.
General Hospital · 279d
Cleared Nov 05, 2015
elance Vital Signs Monitor, Central Monitor Software
K150329 · MHX
Spacelabs Healthcare
Cardiovascular · 268d
Cleared Nov 05, 2015
Tyece OTC TENS Device
K150386 · NUH
Tyece , Ltd.
Neurology · 260d
Cleared Nov 05, 2015
IdentEvent
K150688 · OMB
Optima Neuroscience, Inc.
Neurology · 233d
Cleared Nov 05, 2015
AnsCare ChitoClot Pad
K150963 · QSY
Benq Materials Corporation
General & Plastic Surgery · 209d
Cleared Nov 05, 2015
Nihon Kohden CSM 1901 Bedside Monitor
K151080 · MHX
Nihon Kohden
Cardiovascular · 197d
Cleared Nov 05, 2015
superDimension Navigation System
K151376 · JAK
Covidien, LLC
Radiology · 167d
Cleared Nov 05, 2015
NaturalLine Abutment
K151432 · NHA
Ot Medical GmbH
Dental · 161d