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
36553–36576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2014
PHILIPS IQON SPECTRAL CT
K133674 · JAK
Philips Healthcare (Cleveland)
Radiology · 357d
Cleared Nov 21, 2014
LG SMARTHEALTH
K133997 · DRG
Lg Electronics
Cardiovascular · 329d
Cleared Nov 21, 2014
DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE
K134006 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 329d
Cleared Nov 21, 2014
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
K141377 · LZO
Merete Medical GmbH
Orthopedic · 178d
Cleared Nov 21, 2014
SUDOSCAN
K141872 · GZO
Impeto Medical, Inc.
Neurology · 133d
Cleared Nov 21, 2014
GLIDESHEATH SLENDER
K142183 · DYB
Terumo Medical Corporation
Cardiovascular · 105d
Cleared Nov 21, 2014
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
K142197 · IYN
Konica Minolta, Inc.
Radiology · 102d
Cleared Nov 21, 2014
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT...
K142434 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 21, 2014
PK Lap Loop
K142525 · HIN
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 74d
Cleared Nov 21, 2014
Lesion-Loc Iodine I-125 Seed/Needle
K142668 · KXK
Intramedical Imaging, LLC
Radiology · 63d
Cleared Nov 21, 2014
ZEUS (ZIO ECG Utilization Service) System
K142681 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 63d
Cleared Nov 21, 2014
5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L...
K142868 · GEI
Purple Surgical International Limited
General & Plastic Surgery · 51d
Cleared Nov 21, 2014
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
K143026 · JJX
Aalto Scientific, Ltd.
Chemistry · 31d
Cleared Nov 21, 2014
VEGA Knee System
K143106 · JWH
Aesculap Implant Systems, LLC
Orthopedic · 23d
Cleared Nov 21, 2014
2.3MP Color LCD Monitor, RadiForce MX242W
K143261 · PGY
Eizo Corporation
Radiology · 8d
Cleared Nov 20, 2014
COROENT SYSTEM
K141896 · MAX
Nu Vasive, Incorporated
Orthopedic · 129d
Cleared Nov 20, 2014
FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
K142012 · PIF
Corpak Medsystems
Gastroenterology & Urology · 119d
Cleared Nov 20, 2014
LUNA INTERBODY SYSTEM
K142023 · MAX
Benvenue Medical, Inc.
Orthopedic · 118d
Cleared Nov 20, 2014
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
K142062 · DSY
Vascular Flow Technologies, Ltd.
Cardiovascular · 113d
Cleared Nov 20, 2014
AIXPLORER
K142100 · IYN
Supersonic Imagine
Radiology · 111d
Cleared Nov 20, 2014
NeumoFilt Ergo/Neumo Filt BiteOn
K142303 · BZG
Medical Respiratory Devices S.L.
Anesthesiology · 94d
Cleared Nov 20, 2014
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520 · KTT
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Nov 20, 2014
PhaLinx Hammertoe System
K142585 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 66d
Cleared Nov 20, 2014
Audit MicroControls Linearity LQ Special Diabetes
K142978 · JJY
Aalto Scientific, Ltd.
Chemistry · 36d