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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
56953–56976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 2008
IROOT SP
K080917 · KIF
Innovative Bioceramix, Inc.
Dental · 8d
Cleared Apr 08, 2008
ENTELLUS MEDICAL RS-SERIES SYSTEM
K072302 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 235d
Cleared Apr 08, 2008
DENTAL DIGITAL X-RAY IMAGING SYSTEM
K073365 · MUH
VATECH Co., Ltd.
Radiology · 130d
Cleared Apr 08, 2008
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD...
K073492 · NBW
Tyson Bioresearch, Inc.
Chemistry · 118d
Cleared Apr 08, 2008
TRICOS T RESORBABLE BONE SUBSTITUTE
K073571 · LYC
Baxter Healthcare Corporation
Dental · 110d
Cleared Apr 08, 2008
VERAVIEWEPOCS
K073696 · MUH
J. Morita USA, Inc.
Radiology · 99d
Cleared Apr 08, 2008
S8 ESCAPE II
K080079 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Apr 08, 2008
ZENO PMMA DISC
K080182 · EBG
Wieland Dental + Technik GmbH & Co. KG
Dental · 74d
Cleared Apr 08, 2008
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K080300 · NUV
Cutera, Inc.
General & Plastic Surgery · 63d
Cleared Apr 08, 2008
IGROK
K080325 · LLZ
Igrok, LLC
Radiology · 62d
Cleared Apr 08, 2008
ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER
K080360 · DQY
Endologix, Inc.
Cardiovascular · 57d
Cleared Apr 08, 2008
MODIFICATION TO:PILOT SPINAL SYSTEM
K080502 · MNI
Life Spine
Orthopedic · 43d
Cleared Apr 08, 2008
PROFEMUR LX REVISION 5/8 COATED HIP STEM
K080663 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Apr 08, 2008
K2M COCR ROD
K080792 · MNI
K2m, Inc.
Orthopedic · 19d
Cleared Apr 07, 2008
CRYOSTAT
K072414 · LKX
Lil Drug Store Products, Inc.
Gastroenterology & Urology · 223d
Cleared Apr 07, 2008
CARINA SYSTEM, MODEL 8419350
K072885 · CBK
Draeger Medical AG & Co. KG
Anesthesiology · 181d
Cleared Apr 07, 2008
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM
K073143 · MNI
Vertiflex, Inc.
Orthopedic · 152d
Cleared Apr 07, 2008
US/GS ULTRA WIDE SYSTEM
K073465 · DZE
Osstem Implant Co., Ltd.
Dental · 119d
Cleared Apr 07, 2008
NEXCOMP AND META ETCHANT
K080305 · EBF
Meta Biomed Co., Ltd.
Dental · 62d
Cleared Apr 07, 2008
LDR SPINE ROI-A IMPLANT
K080572 · MQP
Ldr Spine USA
Orthopedic · 38d
Cleared Apr 07, 2008
SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
K080697 · GEX
Global USA Distribution, LLC
General & Plastic Surgery · 26d
Cleared Apr 07, 2008
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
K080800 · IYN
Medison Co., Ltd.
Radiology · 17d
Cleared Apr 04, 2008
ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300
K063437 · JLW
Monobind, Inc.
Chemistry · 507d
Cleared Apr 04, 2008
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE
K070217 · NFO
Neuro Resource Group, Inc.
Neurology · 437d