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

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175,820 results
32977–33000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2016
Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue...
K151405 · NLQ
Surgical Instrument Services and...
General & Plastic Surgery · 245d
Cleared Jan 26, 2016
Tenodesis screw system
K151701 · HWC
Normed Medizin-Technik GmbH
Orthopedic · 216d
Cleared Jan 26, 2016
PATIENT MONITORS VARIOUS MODELS
K151812 · MHX
Philips Medical Systems
Cardiovascular · 208d
Cleared Jan 26, 2016
CenterCross Ultra Catheter
K152456 · DQY
Roxwood Medical, Inc.
Cardiovascular · 151d
Cleared Jan 26, 2016
Vinyl patient examination glove, Powder Free
K153159 · LYZ
Xingyuan Plastic Products Co., Ltd.
General Hospital · 85d
Cleared Jan 25, 2016
Ellipse Supplemental Instrument Trays
K151594 · KCT
Ellipse Technologies, Incorporated
General Hospital · 227d
Cleared Jan 25, 2016
FacetBRIDGE System
K152137 · MRW
Ldr Spine USA
Orthopedic · 178d
Cleared Jan 25, 2016
ImagenSPECT
K152503 · KPS
Cardiovascular Imaging Technologies
Radiology · 145d
Cleared Jan 25, 2016
Magicore System
K152520 · DZE
Innobiosurg Co., Ltd.
Dental · 144d
Cleared Jan 25, 2016
DG PACS
K152977 · LLZ
Dicom Grid, Inc.
Radiology · 109d
Cleared Jan 25, 2016
Fusion Bx
K153166 · LLZ
Focal Healtcare, Inc.
Radiology · 84d
Cleared Jan 25, 2016
Perla Posterior Cervico-Thoracic Fixation system
K153386 · NKG
Spineart
Orthopedic · 63d
Cleared Jan 22, 2016
POCKET NEB
K142541 · CAF
Microvaper Devices
Anesthesiology · 499d
Cleared Jan 22, 2016
SonarMed AirWave, Airway Monitoring System
K143042 · OQU
Sonarmed, Inc.
Anesthesiology · 457d
Cleared Jan 22, 2016
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III...
K151048 · IZQ
Bracco Injeneering
Cardiovascular · 277d
Cleared Jan 22, 2016
Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
K151072 · BSP
Solo-Dex, Inc.
Anesthesiology · 276d
Cleared Jan 22, 2016
Livewire Electrophysiology Catheter
K151617 · NLH
Surgical Instrument Service and...
Cardiovascular · 221d
Cleared Jan 22, 2016
TAURUS C1
K151996 · EIA
Shinhung Company, Ltd.
Dental · 186d
Cleared Jan 22, 2016
Evogue Dental Unit
K152100 · EIA
Takara Belmont Corporation
Dental · 178d
Cleared Jan 22, 2016
VersaOne Bladed Trocar 5mm
K152149 · GCJ
Covidien
General & Plastic Surgery · 172d
Cleared Jan 22, 2016
General & Plastic Surgery Instruments
K152400 · GCJ
Sontec Instruments, Inc.
General & Plastic Surgery · 150d
Cleared Jan 22, 2016
ASAHI Caravel
K152447 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 148d
Cleared Jan 22, 2016
PW Guidewires
K152497 · DQX
Tatara Vascular, LLC
Cardiovascular · 143d
Cleared Jan 22, 2016
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor...
K152670 · GWM
Medos International SARL
Neurology · 127d