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
33145–33168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2016
OTELO LL
K151104 · GAD
Spineart
General & Plastic Surgery · 257d
Cleared Jan 06, 2016
Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
K151287 · DQA
Guangdong Biolight Meditech Co., Ltd.
Anesthesiology · 237d
Cleared Jan 06, 2016
Amendia Interbody Fusion Devices
K151310 · MAX
Amendia, Inc.
Orthopedic · 233d
Cleared Jan 06, 2016
iRestore
K151662 · OAP
Freedom Laser Therapy, Inc.
General & Plastic Surgery · 201d
Cleared Jan 06, 2016
Medline ReNewal Reprocessed Endopath Endoscopic Instruments
K152313 · NUJ
Surgical Instrument Services and...
General & Plastic Surgery · 142d
Cleared Jan 06, 2016
KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
K152604 · PML
Medtronic Sofamor Danek USA,...
Orthopedic · 117d
Cleared Jan 06, 2016
Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing...
K152944 · DPS
Mortara Instrument, Inc.
Cardiovascular · 92d
Cleared Jan 06, 2016
Galaxy UNYCO System
K153233 · KTT
Orthofix Srl
Orthopedic · 58d
Cleared Jan 06, 2016
VasoStat Hemostasis Device
K153259 · DXC
Forge Medical, Inc.
Cardiovascular · 57d
Cleared Jan 06, 2016
ClariVein IC
K153502 · KRA
Vascular Insights, LLC
Cardiovascular · 30d
Cleared Jan 06, 2016
Piccolo Composite® Nailing System
K153536 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 27d
Cleared Jan 05, 2016
VENTURI MiNO TG600/14
K143004 · OMP
Talley Group, Ltd.
General & Plastic Surgery · 442d
Cleared Jan 05, 2016
FloSure Ventilation Patch
K150459 · OMP
Simex Medizintechnik GmbH
General & Plastic Surgery · 316d
Cleared Jan 05, 2016
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
K151771 · JXM
Immunalysis Corporation
Toxicology · 189d
Cleared Jan 05, 2016
SoloPath Re-Collapsible Access System
K152498 · DYB
Onset Medical Corporation
Cardiovascular · 126d
Cleared Jan 05, 2016
MyOn HC Manual Wheelchair
K152536 · IOR
Invacare Corporation
Physical Medicine · 123d
Cleared Jan 05, 2016
K2M Fenestrated Tap System
K152872 · KNW
K2m
Gastroenterology & Urology · 97d
Cleared Jan 05, 2016
Quell
K152954 · NUH
Neurometrix, Inc.
Neurology · 90d
Cleared Jan 05, 2016
Zenysis Short-Term Dialysis Catheter
K153190 · MPB
C.R. Bard, Inc.
Gastroenterology & Urology · 63d
Cleared Jan 05, 2016
New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
K153265 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 54d
Cleared Jan 04, 2016
InMode FRF Applicator
K151273 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 236d
Cleared Jan 04, 2016
ROSA Spine
K151511 · OLO
Medtech S.A
Orthopedic · 214d
Cleared Jan 04, 2016
LOGIQ V1/ LOGIQ V2
K153037 · IYN
GE Medical Systems Ultrasound &...
Radiology · 77d
Cleared Jan 04, 2016
Erchonia PL Touch
K153052 · NHN
Erchonia Corporation
Physical Medicine · 76d