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
31657–31680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2016
ARTLINE
K160448 · DQY
Health Line International Corporation
Cardiovascular · 145d
Cleared Jul 12, 2016
Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/...
K161055 · KPI
Fuji Dynamics , Ltd.
Gastroenterology & Urology · 89d
Cleared Jul 12, 2016
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
K161175 · JWY
Liofilchem S. R. L.
Microbiology · 77d
Cleared Jul 12, 2016
CryoDose H or Similar
K161337 · GEH
Nuance Medical, LLC
General & Plastic Surgery · 60d
Cleared Jul 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161640 · NRY
Penumbra, Inc.
Neurology · 28d
Cleared Jul 12, 2016
E-Pack Procedure Kit
K161726 · GAM
Ethicon, Inc.
General & Plastic Surgery · 20d
Cleared Jul 11, 2016
JSM Insulin Pen Needle
K152166 · FMI
Jeesung Medical Co., Ltd.
General Hospital · 342d
Cleared Jul 11, 2016
Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/...
K152511 · HRX
Prosurg, Inc.
Orthopedic · 313d
Cleared Jul 11, 2016
Pulse H20h!
K152628 · NUC
Toaster Labs, Inc.
Obstetrics & Gynecology · 300d
Cleared Jul 11, 2016
Pulse Aloe-ahh
K152671 · NUC
Toaster Labs, Inc.
Obstetrics & Gynecology · 297d
Cleared Jul 11, 2016
ACE Electrosurgical Resection and Vaporization Electrodes Series
K153055 · GEI
Ace Medical Devices Pvt. , Ltd.
General & Plastic Surgery · 265d
Cleared Jul 11, 2016
MLX™ - Medial Lateral Expandable Lumbar Interbody System
K153105 · MAX
Nu Vasive, Incorporated
Orthopedic · 258d
Cleared Jul 11, 2016
PROW FUSION-V
K153786 · MAX
Nlt Spine, Ltd.
Orthopedic · 193d
Cleared Jul 11, 2016
PeriCoach OTC
K160758 · HIR
Analytica, Ltd.
Gastroenterology & Urology · 115d
Cleared Jul 11, 2016
Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves...
K160875 · KGO
Cardinal Health, Inc.
General Hospital · 103d
Cleared Jul 11, 2016
PASS OCT Spinal System
K161149 · NKG
Medicrea International SA
Orthopedic · 77d
Cleared Jul 11, 2016
da Vinci Xi Surgical System
K161271 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 67d
Cleared Jul 11, 2016
syngo®.via protoNeo (Version VA10A)
K161685 · LLZ
Siemens Healthcare GmbH
Radiology · 24d
Cleared CT Jul 09, 2016
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
K153272 · GXI
Relievant Medsystems
Neurology · 240d
Cleared Jul 08, 2016
BD U-500 INSULIN SYRINGE
K151870 · FMF
Becton, Dickinson and Company
General Hospital · 365d
Cleared Jul 08, 2016
The Time Machine Series Lasers
K152461 · ILY
Medical Lasers Manufacturer, Inc.
Physical Medicine · 315d
Cleared Jul 08, 2016
Alta ACDF System
K152622 · OVE
Biomet Spine
Orthopedic · 298d
Cleared Jul 08, 2016
PlasmaBlade TnA Tonsil and Adenoid Dissection Device
K152703 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 291d
Cleared Jul 08, 2016
Savannah-T® Pedicle Screw System
K152920 · NKB
Amendia, Inc.
Orthopedic · 280d